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

Model Number	ZCU525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The zcu525 model intraocular lens (iol) was implanted in the patient¿s operative eye.In a secondary surgical procedure, the iol was explanted due to complaints of a power miss, and the explanted iol was replaced with a zcu525 29.5 iol.The incision was enlarged and unplanned sutures were required during the lens exchange procedure however, there was no vitrectomy.The iol directions for use were followed.Best corrected visual acuity (bcva) pre-operative was reported as 20/30 and post-operative results were not provided.Patient prognosis post lens exchange was reported as temporarily impaired.No further information is available.
Additional Manufacturer Narrative
Additional information: section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes section d-9: device date returned to manufacturer: 05-aug-2025 section h-3: device evaluated by manufacturer: yes device evaluation: the lens was received inside a specimen up.During a visual inspection, the device was inspected under magnification.The lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected revealing damage and chips on the edge of the lens.No further issues were identified and no further evaluation was performed.The complaint lens was forwarded to the manufacturing site for miq re-measurement.The lens was measured resulting in a 33.71 diopter, confirming that the product is within the optical power range.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.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: 22556232
• Report Number: 3012236936-2025-000199
• Device Sequence Number: 21226636
• Product Code: HQL
• UDI-Device Identifier: 05050474664555
• UDI-Public: (01)05050474664555(17)260211
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/26/2025

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: 02/11/2026
• Device Model Number: ZCU525
• Device Catalogue Number: ZCU525U335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown