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

Model Number	ZCU600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown/not provided.The best estimate date is on or prior to feb 12, 2026.Section d6a: if implanted; give date: unknown/ requested but not provided.Section d6b: if explanted; give date: unknown/ requested but not provided.Section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a non-preloaded toric monofocal intraocular lens (iol) was explanted after the patient experienced worsened visual acuity following cataract surgery, despite best correction in both eyes (ou).Although the patient¿s manifest refraction was close to plano, visual acuity remained worse than pre-operative levels.Post-operative examination demonstrated acceptable clinical findings in both eyes, with the iols well positioned and only minimal posterior capsular opacification (pco).Repeat corneal topography showed irregular astigmatism.Lamellar keratectomy with mitomycin-c (mmc) was discussed as a treatment option, including the potential for refractive changes and the possible future need for glasses or contact lenses.The patient elected to proceed with keratectomy.Following the procedure, a refractive change occurred, and the patient subsequently chose to undergo an iol exchange.No patient harm was reported.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 24551439
• Report Number: 3012236936-2026-000063
• Device Sequence Number: 21183287
• Product Code: HQL
• UDI-Device Identifier: 05050474665286
• UDI-Public: (01)05050474665286(17)260927
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Model Number: ZCU600
• Device Catalogue Number: ZCU600U110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30-12 AND PLATINUM IOL INSERTER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male