MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number ZCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Visual Disturbances (2140); Halo (2227); Discomfort (2330)

Event Date 12/14/2021

Event Type  Injury  

Event Description

The following article was received based on literature review.Article: a one year longitudinal comparative analysis of visual outcomes between femtosecond laser-assisted cataract surgery and standard phacoemulsification cataract.A retrospective, single-center comparative study was done to assess visual outcomes over time of femtosecond laser-assisted cataract surgery (flacs) compared to standard phacoemulsification cataract surgery (pcs).A total of 298 eyes were divided to pcs group (n=155eyes) and flacs group (n=143 eyes) and were analyzed at 1 week, 3 months, and 1 year.Patients undergoing flacs were treated with the catalys femtosecond laser system (precision lens, bloomington, mn).Phacoemulsification was performed in a divide-and- conquer fashion using the white star signature phacoemulsification system (advanced medical optics inc, inc.Santa ana, ca).Implanted intraocular lenses (iols) were either toric or non-toric.Among these included iols from the tecnis platform (johnson & johnson) and amo (abbott medical optics): zcb00, tecnis monofocal 1-piece iol (pcs [n=26 eyes]; flacs [n=22 eyes]); za, tecnis monofocal 3-piece iol (flacs [n=2 eyes]); zct/zcu, tecnis toric ii iol (pcs [n=21 eyes]; flacs [n=26 eyes]); zku, tecnis multifocal toric ii iol (flacs [n=3 eyes]); zma, tecnis multifocal iol (pcs [n=1 eye]); zxr00, tecnis symfony iol (pcs [n=5 eyes]; flacs [n=2 eyes]); zxt, amo symfony toric iol (pcs [n=30 eyes]; flacs [n=29 eyes]).There were other iols used from other manufacturers.Complications included: postoperative loss of 1 line (change in snellen bdva): psc group = 10% (n=5 eyes); flacs group = 2% (n=1 eye).At 3 months postoperative: glare: flacs (n=1 eye).Halo: pcs (n=3 eyes); flacs (n=8 eyes).Photophobia: pcs (n=2 eyes).Dry eyes: pcs (n=6 eyes); flacs (n=13 eyes).Night vision issues: pcs (n=6 eyes); flacs (n=3 eyes).At 1 year postoperative: dry eyes: pcs (n=5 eyes); flacs (n=11 eyes).Postoperative procedures included: yag (yttrium aluminum garnet) laser capsulotomy (= 3 months post-op): pcs (n=1 eye): flacs (n=1 eye).Yag laser capsulotomy (= 1-year post-op): pcs (n=5 eyes); flacs (n=8 eyes).Limbal relaxing incisions: flacs = (n=6 eyes).It is unclear however, if it were our devices or the other devices in the study that were used or implanted in the eye that caused these events.There were no further interventions reported.A copy of the article is provided with this report.This report is for the intraocular lens, model zcb00.Separate reports are being submitted for the other listed models.

Manufacturer Narrative

Age/date of birth: group pcs: 66 ± 9[37¿86] and group flacs: 68 ± 9 [41¿89] (years).Sex/gender: group pcs: male: 60 (38.7), female: 95 (61.3).Group flacs: male: 66 (46.2), female: 77 (53.8).Section b3: date of event: (b)(6) 2021 (the date article was published).(b)(4).Moshirfar m., waite aj., ellis jh., huynh r., placide j., barke mr., mccabe se., ronquillo yc., hoopes pc jr., bradley mj., hoopes pc.(2021).A one year longitudinal comparative analysis of visual outcomes between femtosecond laser-assisted cataract surgery and standard phacoemulsification cataract surgery.Clin ophthalmol.15(1), pp.4667-4680.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15230861
• MDR Text Key: 297951693
• Report Number: 3012236936-2022-02174
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: UNK-ZCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention