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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown; information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the surgeon that the non-preloaded monofocal intraocular lens (iol) moved forward more tightly than usual while being loaded.During the implantation process, a sudden jerk occurred, leading to a minor crack in the lens and causing pain at the implantation site.Despite this, the lens was successfully implanted in the patient's eye, and the patient is currently stable.The issue was noted during the insertion of the lens into the eye when the cartridge tip came into contact with the eye.Upon follow-up, it was stated that there was no user error and the patient is better now.No further information is available.

• 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: 22079123
• Report Number: 3012236936-2025-000141
• Device Sequence Number: 8530847
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)280628
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: ZCB00
• Device Catalogue Number: ZCB0000205
• 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: 04/25/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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