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 Codes	Macular Edema (1822); Blurred Vision (2137)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The zcb00 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Patient stated he did not see within the first three (03) days after surgery and then he had blurry vision.His vision prior to the surgery was good.He was put on steroids for a year after the implant to get inflammation down in the macula.Patient had low eye angles and was advised that this was being addressed and he could have cataract surgery too and that he would not need lasik done.He is scheduled to see the doctor and have a yttrium aluminum garnet (yag) done in three (03) weeks and the doctor discussed performing a vitrectomy at this time as well.Patient has type ii diabetes.He now sees a retina specialist and was told the fluid is no longer there, but he still has problems with the right eye.The suspect iol is not available for return as it remains implanted.The yag and vitrectomy procedures have not been confirmed to have taken place.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 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.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & 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: 21965283
• Report Number: 3012236936-2025-000126
• Device Sequence Number: 20865858
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)230927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 09/27/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000225
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2019
• 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: 65 YR
• Patient Sex: Male