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

Model Number	ZCU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, and risk documentation for this device 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 that an explant occurred due to a refractive surprise.There was no patient injury reported.The lens was removed during a secondary surgical procedure and replaced with the same model but a higher diopter intraocular lens.Additional information revealed that there was a calculation issue, as both the pentacam and ora suggested the use of this lens, but the patient ended up with a significant refractive error afterward.On (b)(6) 2025, it was noted that the patient¿s vision was not good.However, a one-week refraction check revealed that the patient still had a considerable amount of astigmatism that needed correction.The patient is doing better now.There was some corneal edema from the second procedure, but it is clearing up.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: 22457938
• Report Number: 3012236936-2025-000183
• Device Sequence Number: 8315182
• Product Code: HQL
• UDI-Device Identifier: 05050474659056
• UDI-Public: (01)05050474659056(17)291202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U240
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White