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

Model Number	ZCU300
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: not applicable, as there was no patient contact.Section d6a: if implanted, give date: not applicable, as there was no patient contact.Section d6b: if explanted, give date: not applicable, as there was no patient contact.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 additional information; however, no further information has been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during preparation of a non-preloaded monofocal intraocular lens (iol), the surgical technician noticed an opaque imperfection on the lens.No patient contact occurred.No further information was provided.
Additional Manufacturer Narrative
Corrected data: the following fields were updated based on the additional information received: section b3: december 2, 2025.Section e1 (email address): (b)(6).Additional information: section b5: additional information received indicated that the procedure was completed using a backup/replacement lens.No patient injury was reported.There were no unplanned medical or surgical interventions, such as vitrectomy, incision enlargement, or the need for sutures.The device was determined to have caused or contributed to the event.The patient outcome was good.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: 23912083
• Report Number: 3012236936-2025-000340
• Device Sequence Number: 9093068
• Product Code: HQL
• UDI-Device Identifier: 05050474660113
• UDI-Public: (01)05050474660113(17)300429
• 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
• 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): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U180
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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
• Patient Sex: Unknown