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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The zcb00 model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Posterior capsule opacification was noted during (b)(6) 2024 yttrium aluminum garnet (yag) evaluation and was resolved by performing yag laser capsulotomy on (b)(6) 2024.Patient prognosis post-procedure was reported as fully recovered.The suspect iol is not available for investigation as it remains implanted.The iol directions for use were followed.No further information is available.
Additional Manufacturer Narrative
Additional information: section a3b: patient gender: male.Section a4: patient weight: unknown/asked information was not provided.Section d6b: date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h3: device evaluated by manufacturer: the complaint device was not returned for evaluation as it remains implanted.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 report will be filed.Section h-6 health effect - impact code: 4625 ¿ yag capsulotomy.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the reported event has been previously reported under medwatch report number #3012236936-2025-0003224.Therefore, this file is no longer considered reportable.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 24818222
• Report Number: 3012236936-2026-000090
• Device Sequence Number: 15874859
• Product Code: HQL
• UDI-Device Identifier: 05050474531635
• UDI-Public: (01)05050474531635(17)231107
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 11/07/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White