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

Model Number	ZA9003
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/asked but not provided.Section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect: clinical code: 4581 incisions enlarged.Section h6: health effect: impact code: 4625 for unplanned vitrectomy and incision enlarged.An attempt was made to obtain missing information; however, the account did not have the information.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 defective.The lens was partially delivered in the patient's left eye and then removed.Removal and replacement happened during the same procedure.The procedure was completed successfully with another johnson & johnson lens (same model and diopter).An incision enlargement and a vitrectomy were required; however, a suture was not required.There was no other medical or surgical intervention.The patient is doing fine post-operatively.Through follow up, it was clarified that the surgeon stated the lens loaded correctly, but the surgeon could not fully advance it into the patient's eye.The lens was partially inserted and the surgeon started to manipulate the lens with the chopper and it somehow interfered with the leading haptic.At this point, the patient's eye became unstable requiring an incision enlargement and an unplanned vitrectomy was performed.The lens is not available as it was discarded.No additional information was provided.

• 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: 22172551
• Report Number: 3012236936-2025-000161
• Device Sequence Number: 9218503
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)270816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030205
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD CARTRIDGE LOT #CP14987.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female