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J CATARACT REFRACT SURG - VOL 32, JUNE 2006

Opacification of the Hydroview H60M

intraocular lens: Total patient recall

Chinnasamy Balasubramaniam, MS, DNB, FRCS(Ed), Jonathan Goodfellow, MBBS,

Nick Price, FRCS, FRCOphth, Nigel Kirkpatrick, MD, FRCOphth

PURPOSE: To report the prevalence of intraocular lens (IOL) opacification and related clinical featuresin patients implanted with Hydroview IOL.

SETTING: Gloucestershire Eye Unit, Gloucestershire, United Kingdom.

METHODS: A total of 1330 eyes of 1265 patients who had cataract surgery with Hydroview IOL implan-tation between September 2000 and April 2001 were reviewed between April and October 2004. Thevisual acuity, visual symptoms, IOL status, and associated ocular comorbidity were recorded.

RESULTS: One hundred ninety-three (14.5%) of 1330 eyes had evidence of IOL opacification. A total of56 (4.2%) had visually significant opacification and had IOL exchange. The prevalence of IOL opacifi-cation ranged from 1.1% in patients who had surgery in September 2000 to 36.3% in the December2000 group. In eyes with IOL opacification, the visual symptoms were decreased vision (57%), glare(32%), and mistiness of vision (27%). One hundred forty-four eyes (75%) with IOL opacification had vi-sual acuity of 6/12 or better; 21.5% of diabetic eyes had IOL opacification compared with 14.3% of non-diabetic eyes (P Z.06); 20.5% of glaucomatous eyes had IOL opacification compared with 14.0% ofnonglaucomatous eyes (P Z .033).

CONCLUSIONS: This is the first large sample recall of patients implanted with the Hydroview H60MIOL. The overall prevalence of IOL opacification was 14.5%, with peak prevalence in patients whohad surgery in December 2000.

J Cataract Refract Surg 2006; 32:944–948 Q 2006 ASCRS and ESCRS

Opacification of the intraocular lens (IOL) is a potentially

serious complication of IOL implantation. The Hydroview

H60M (Bausch & Lomb) IOL, a hydrophilic acrylic lens,

has been associated with reports of late postoperative opa-

cification.1–10 After increasing reports of opacified Hydro-

view IOLs in the authors’ unit and other centers in theUnited Kingdom in late 2003, a meeting at the Royal

Accepted for publication December 23, 2005.

From the Department of Ophthalmology, Cheltenham GeneralHospital, Cheltenham, United Kingdom.

No author has a financial or proprietary interest in any material ormethod mentioned.

The recall of patients was sponsored by Bausch & Lomb, Roches-ter, New Jersey, USA. Robert Jones and Saraniya Sachi Balasubra-maniam helped in data collection and analysis.

Reprint requests to Chinnasamy Balasubramaniam, MS, DNB,FRCS(Ed), Department of Ophthalmology, Cheltenham GeneralHospital, Sandford Road, Cheltenham, GL53 7AN, United King-dom. E-mail: ophthal-bala@excite.com.

06 ASCRS and ESCRS

hed by Elsevier Inc.

College of Ophthalmologists, London, was convened in

January 2004 to discuss the problem among units that

used this type of IOL. Most cases of IOL opacification arose

from surgery performed between autumn 2000 and winter

2001. It was decided that 1 unit would recall all their pa-

tients who had had Hydroview IOL implantation in theidentified critical time period. The authors’ unit was ap-

pointed to undertake the total recall to assess the extent

of the problem. The process and outcome of the recall are

discussed here.

PATIENTS AND METHODS

Patients who had cataract surgery with Hydroview IOL im-plantation between September 2000 and April 2001 were identi-fied from theater records. A multidisciplinary approach was usedfor the recall, with the clinical risk department coordinating theprocess. Letters were sent to the patients, general practitioners,and optometrists to inform them of the recall. Embargoed pressreleases were also given to newspapers. A dedicated call centerwas set up to organize the appointments, which were prioritizedaccording to patient symptoms. Patients having periodic clinicreview for other reasons were also given an appointment

0886-3350/06/$-see front matterdoi:10.1016/j.jcrs.2006.02.047

PATIENT RECALL RESULTING FROM IOL OPACIFICATION

specifically for IOL assessment. Review took place in speciallyset up consultant-run clinics between April and October 2004.Twenty patients were reviewed per clinic. Data were collectedon a proforma sheet by both the clinic nurse and doctor. Detailsrecorded during the assessment included the date and type ofoperation originally performed, surgical complications, best cor-rected visual acuity (BCVA), visual symptoms, ocular comorbid-ity, diabetic status, presence of IOL opacification, and presenceof posterior capsule opacification (PCO). The records of patientswho had already had IOL exchange for IOL opacification beforethe recall were reviewed, and a proforma sheet was completed.Patients were then discharged, advised to have surgery forvisually significant IOL opacification, or given a follow-upappointment for visually insignificant IOL opacification or otherocular comorbidity as necessary. The Pearson c2 test was usedfor statistical analysis.

RESULTS

A total of 2162 patients implanted with the H60M IOLbetween September 2000 and April 2001 were identified

from theater logbooks. Four hundred fifty-four patients

were deceased by the time of recall according to the hospi-

tal database. Of the remaining 1708 patients, 26 had already

had or were scheduled for IOL exchange, 49 had declined

an appointment, 22 had moved out of the area, 14 were

deceased, and 4 were too ill to attend clinic. Two hundred

nine patients could not be contacted. The recall process re-sulted in 1384 patients being offered a clinic appointment;

491 were prioritized as urgent because of their symptoms

and 893 as nonurgent appointments; 1265 patients (mean

age 78.9 years G 9.33 (SD); range 35 to 100 years) attended

clinic for review, 65 of whom had both eyes examined. The

operative procedures performed at the time of the original

IOL implantation were phacoemulsification in 97.5%, com-

bined phacoemulsification and trabeculectomy in 1.7% and‘‘others’’ (conventional extracapsular cataract extraction,

combined phacoemulsification, and pars plana vitrectomy)

in 0.8%.

J CATARACT REFRACT SUR

Intraocular Lens Opacification

One hundred ninety-three of 1330 eyes (14.5%) exam-ined had evidence of IOL opacification. Two patients had

bilaterally opacified IOLs. The prevalence of IOL opacifica-

tion ranged from 1.1% in patients who had surgery in Sep-

tember 2000 to 36.3% in the December 2000 group

(Figure 1). The amount of opacification of the lens was var-

iable, ranging from small localized patches to dense diffuse

opacification obscuring any fundal view. Diffuse opacifica-

tion was noted in 88.5% and localized opacification in11.5% (Figures 2 and 3).

Symptoms and Visual Acuity

Visual symptoms were assessed in 1288 eyes, of which

772 were asymptomatic and 516 were symptomatic. Forty-

two (5.4%) of the asymptomatic eyes and 151 (29%) of the

symptomatic eyes had IOL opacification. One hundred ten

eyes (57%) with IOL opacification had symptoms of de-

creased vision. Sixty-two (32%) had glare, and 52 (27%)

had mistiness. The distribution of BCVA in eyes with and

without IOL opacification is shown in Figure 4. A total of144 eyes (75%) with IOL opacification had visual acuity

of 6/12 or better. In the subgroup of 52 eyes with IOL opa-

cification and 6/6 or better vision, 21 (40%) still com-

plained of glare and 11 (21%) of mistiness.

Comorbidity

Comorbidity data were available for analysis in 1240

eyes. Seven hundred thirty eyes had no comorbidity, and

510 eyes had 1 or more comorbidity, for which the distribu-

tion is shown in Figure 5. Ninety-three eyes had diabetes

(Table 1). A total of 21.5% of diabetic eyes had IOL opaci-fication compared with 14.3% of nondiabetic eyes (P Z.06)

(Table 2). A total of 156 eyes had glaucoma (Table 1). A to-

tal of 20.5% of glaucomatous eyes had IOL opacification

0

50

100

150

200

250

2000Sep

2000Oct

2000Nov

2000Dec

2001Jan

2001Feb

2001M

ar

2001Apr

Eyes

Opacified Not opacified

1.17.0

17.5

36.3

27.0

12.110.1

4.6

Figure 1. Distribution of IOL opacification with the

month of implantation.

G - VOL 32, JUNE 2006 945

PATIENT RECALL RESULTING FROM IOL OPACIFICATION

Figure 2. Diffuse IOL opacification. Left: Anterior sur-

face. Right: Posterior surface.

compared with 14.0% of nonglaucomatous eyes (P Z.033)

(Table 3).

Outcomes

Fifty-six of 193 eyes (4.2% of total recall) had visuallysignificant IOL opacification, and patients were advised to

have IOL exchange. The remaining 137 patients were ad-

vised follow-up to monitor any progression of IOL opacifi-

cation. Two hundred seventy-five patients were given

follow-up clinic appointments for other reasons, such as

glaucoma or laser capsulotomy for PCO.

DISCUSSION

The prevalence of IOL opacification in this cohort of

patients approximately 3 years postimplantation was

14.5%. The manufacturers reported in 2002 an incidence

of only 0.3% (309/4000). Yu et al.6 reported that 46 eyes

of 498 Hydroview IOL implantations were detected to beopacified, and the risk for opacification of a Hydroview

IOL at their center was found to be 9%. The investigators

in this study did not, however, review all patients, as we

did, which could explain the lower prevalence than that

in our study group. To our knowledge, this is the first

large-sample recall of patients who received the Hydroview

IOL.

Histopathologic analysis of the opacified HydroviewIOL by Werner et al.7 found that the opacification is primar-

ily caused by calcium deposition on the surface of the IOL.

The manufacturers (C. Guttman, ‘‘Hydroview Calcification

Resolved,’’ Ophthalmology Times 2001, 26[4]) and Dorey

et al.11 also reported that the opacification may be linked

to the migration of silicone from the Surefold packaging

onto the lens surface followed by the attraction of the cal-

cium ions to the lens surface. The packaging system con-taining silicone was in use from December 1997 until

May 2001, when the manufacturers replaced hospital

stocks with lenses supplied in silicone-free packaging.

J CATARACT REFRACT SURG946

Because the IOLs used throughout our study period had

the same Surefold silicone package, this theory would

lead one to expect a reasonably uniform incidence of opa-

cification within the study period. However, this was not

the case: There was a highly significant variation in the

prevalence of IOL opacification depending on the time of

implantation, varying from 1.1% in September 2000, peak-

ing at 36.3% in December 2000, and falling back to 4.7% byApril 2001. Other than changes in the packaging in Decem-

ber 1997 and May 2001, the manufacturer has confirmed

that there had not been any change in manufacturing

parameters in the IOLs used during the study period. The

reason for the highly significant variation in the incidence

of IOL opacification remains unclear.

Figure 3. Localized IOL opacification.

- VOL 32, JUNE 2006

PATIENT RECALL RESULTING FROM IOL OPACIFICATION

Since 2001 in the United Kingdom, the Medical De-vices Alert (MDA) in the U.K. and the manufacturer have

been monitoring the reports of opacification and associated

explantation. Three hundred four of the total 88 527

Hydroview lenses supplied to the United Kingdom in the

silicone-containing packaging were explanted for lens

opacification (letter from MDA issued April 5, 2004,

Ref. MDA/2004/015). A total of 4.2% in our study had

IOL exchange. Rimmer et al. from Peterborough, U.K.reported a similar rate (4%) of IOL exchange for Hydroview

lenses implanted between September 2000 and April 2001

(Simultaneous Outbreak of IOL Calcification in U.K.: 140

Exchanges in 1 District Hospital and National Survey,

presented at the American ASCRS Symposium on Society

of Cataract, IOL and Refractive Surgery, Washington

D.C., USA, April 2005). These figures are considerably

higher than the 0.3% of IOL exchange rate in the U.K. re-ported initially by the manufacturer.

The opacification was diffuse in 88.5%. Yu et al.6 also

reported that 93% had generalized opacification of the

IOL. As reported in their study, we also observed that

some eyes had localized opacification; this opacification

was paired and linear, corresponding to forceps marks. In

0

100

200

300

400

500

Eyes

6/5

6/6

6/9

6/1

2

6/1

8

6/2

4-6

/60

wors

e

not re

cord

ed

Opacified Not opacified

Figure 4. Distribution of BCVA in eyes with and without IOL opacification.

0

20

40

60

80

100

120

140

nu

mb

er o

f eyes

Diabetes

ARMD

Glaucoma

Ambylo

pia

Uveitis

Other

IOL opacification No IOL opacification

Figure 5. Distribution of comorbidities in eyes with and without IOL

opacification.

J CATARACT REFRACT SUR

eyes with diffuse opacification, forceps marks were fre-quently noted to be less or more opaque than the surround-

ing IOL surface.

A total of 27% of patients had a BCVA of 6/6 or better,

despite the presence of IOL opacification. Hollick et al.12

reported that in eyes with PCO, visual acuity is not

a good measure of visual function because the visual dete-

rioration from PCO is caused by forward light scatter cast-

ing a veiling luminance on the retina. It is possible thatopacification of the IOL causes similar light scattering,

thereby causing symptoms such as glare (in 40% of eyes)

and mistiness (in 21% of eyes). We are currently studying

in detail other forms of visual function such as contrast sen-

sitivity in the subgroup of patients with good vision and

IOL opacification not yet requiring IOL exchange.

Blood–aqueous barrier impairment might be increased

with intraoperative complications or associated medicalconditions. A case-control retrospective study done by

the manufacturers found that a compromised blood–retinal

barrier seemed to be associated with the presence of IOL

calcification (unpublished data). Studies have found

a high percentage of associated conditions such as glau-

coma and diabetes in patients with hydrogel IOL opacifica-

tion.6–9,13 In our study, there was no significant association

between IOL opacification and diabetes. However, the asso-ciation with glaucoma was significant (P Z.033) and war-

rants further evaluation. A bias toward more detailed

completion of the data forms (and therefore recording of

comorbidities) for eyes with IOL opacification cannot be

ruled out.

Table 1. Distribution of diabetes and glaucoma.

Month of Surgery No. of Eyes Diabetes (%) Glaucoma (%)

September 182 10 (5.5) 17 (9.3)October 171 17 (9.9) 21 (12.3)November 182 17 (9.3) 28 (15.4)December 146 10 (6.8) 16 (11.0)January 200 11 (5.5) 21 (10.5)February 141 6 (4.3) 15 (10.6)March 158 14 (8.9) 22 (13.9)April 150 8 (5.3) 16 (10.7)Total 1330 93 (7.0) 156 (11.7)

Table 2. Correlation between diabetes and IOL opacification.

IOL Opacification (P Z .06)

Diabetes, n (%)

Yes No

Yes 20 (21.5) 164 (14.3)No 73 (78.5) 983 (85.7)Total 93 (100) 1147 (100)

G - VOL 32, JUNE 2006 947

PATIENT RECALL RESULTING FROM IOL OPACIFICATION

One hundred thirty-seven eyes with visually insignifi-

cant opacification are being followed in the clinic. The re-

quired frequency and duration of the follow-up for these

patients are not yet clear. There is not much evidence in

the literature regarding the nature of progression of IOL

opacification, especially 3 years after the initial implanta-

tion. Further studies are required to answer this question

so that robust advice may be offered to patients regardingfollow-up protocol and prognosis. We are planning to re-

view the patients for a further 2 years.

Opacification of the IOL has potential medicolegal

implications. After discussion with our hospital legal de-

partment, it was decided that patients who had surgery be-

tween September 2000 and April 2001 would be informed

of the potential risk for IOL opacification. Because the

primary aim was to discover the actual prevalence of thiscomplication, we recalled all patients for review. Other

centers in the U.K. that have used the Hydroview IOL

have reviewed only the symptomatic patients (personal

communication). We found that 21.8% of all eyes with

IOL opacification were asymptomatic. If only symptomatic

patients had been recalled, it is likely that a significant pro-

portion of patients with IOL opacification would be missed.

However, because patients are not offered any treatmentunless symptomatic, the process of recalling all patients

may not be warranted considering the financial implica-

tions and increased concern among patients.

The process of recalling such a large group of patients

is usually difficult. Eighty-six percent of the contacted pa-

tients attended the clinic for review. We believe that this

is a high proportion considering the large number and

age of patients involved, and we attribute the success tothe multidisciplinary approach involved in the recall pro-

cess. The multidisciplinary team included the hospital ex-

ecutives who gave the initial press release, administrative

staff who sent the initial letters and booked the appoint-

ments, ophthalmic staff nurses who manned the telephone

Table 3. Correlation between glaucoma and IOL opacification.

IOL Opacification (P Z .033)

Glaucoma

Yes No

Yes 32 (20.5) 152 (14)No 124 (79.5) 932 (86)Total 156 (100) 1084 (100)

J CATARACT REFRACT SURG -948

helpline and prioritized appointments, and the consultant

ophthalmologists who reviewed the patients. This recall

model could be adopted for similar recalls.

The recall process used was successful in enabling clin-

ical review of the majority of patients implanted with po-

tentially defective intraocular lenses. A total of 14.5% ofeyes examined in this study had evidence of IOL opacifica-

tion. The peak prevalence of IOL opacification was in IOLs

implanted in December 2000, with reducing prevalence

3 to 4 months either side of this; the cause of this variation

remains unclear, and further studies are required to give

a proper explanation.

REFERENCES

1. Apple DJ, Werner L, Escobar-Gomez M, Pandey SK. Deposits on the

optical surfaces of Hydroview intraocular lenses [letter]. J Cataract

Refract Surg 2000; 26:796–797

2. Murray RI. Two cases of late opacification of the Hydroview hydrogel

intraocular lens [letter]. J Cataract Refract Surg 2000; 26:1272–1273

3. Yu AKF, Shek TWH. Hydroxyapatite formation on implanted hydrogel

intraocular lenses. Arch Ophthalmol 2001; 119:611–614

4. Sharma TK, Chawdhary S. The opalescence of hydrogel intraocular

lens [letter]. Eye 2001; 15:97–98

5. Fernando GT, Crayford BB. Visually significant calcification of hydrogel

intraocular lenses necessitating explantation. Clin Exp Ophthalmol

2000; 28:280–286

6. Yu AKF, Kwan KYW, Chan DHY, Fong DYT. Clinical features of 46 eyes

with calcified hydrogel intraocular lenses. J Cataract Refract Surg

2001; 27:1596–1606

7. Werner L, Apple DJ, Escobar-Gomez M, et al. Postoperative deposition

of calcium on the surfaces of a Hydrogel intraocular lens. Ophthalmol-

ogy 2000; 107:2179–2185

8. Habib NE, Freegard TJ, Gock G, et al. Late surface opacification of

Hydroview� intraocular lenses. Eye 2002; 16:69–74

9. Izak AM, Werner L, Pandey SK, Apple DJ. Calcification of modern fold-

able hydrogel intraocular lens designs. Eye 2003; 17:393–406

10. Mamalis N, Davis B, Nilson CD, et al. Complications of foldable intraoc-

ular lenses requiring explantation or secondary interventiond2003

survey update. J Cataract Refract Surg 2004; 30:2209–2218

11. Dorey MW, Brownstein S, Hill VE, et al. Proposed pathogenesis for the

delayed postoperative opacification of the Hydroview hydrogel intra-

ocular lens. Am J Ophthalmol 2003; 135:591–598

12. Hollick EJ, Spalton DJ, Ursell PG, et al. Posterior capsular opacification

with hydrogel, polymethylmethacrylate, and silicone intraocular

lenses: two-year results of a randomized prospective trial. Am J Oph-

thalmol 2000; 129:577–584

13. Pandey SK, Werner L, Apple DJ, Kaskaloglu M. Hydrophilic acrylic intra-

ocular lens optic and haptics opacification in a diabetic patient; bilat-

eral case report and clinicopathologic correlation. Ophthalmology

2002; 109:2042–2051

VOL 32, JUNE 2006