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	Visual Impairment (2138)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section h3: the 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 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 monofocal intraocular lens (iol) was explanted from a patient's right eye due to refractive error.The explanted iol was replaced with another lens of the same model of higher diopter 23.0d.The patient outcome was not provided.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: feb 4, 2026 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection of the complaint device reveal that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no issues that could contribute to the complaint were observed.During the product evaluation it was confirmed that the physical characteristics of the lens matched a zcb00 model lens.The complaint issues were not identified during product evaluation.The observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency 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: 24300131
• Report Number: 3012236936-2026-000035
• Device Sequence Number: 9408394
• Product Code: HQL
• UDI-Device Identifier: 05050474531741
• UDI-Public: (01)05050474531741(17)290228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000215
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: 74 YR
• Patient Sex: Female