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

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.Section b3: date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2025 [implant date] and (b)(6) 2026 [alert date].Section d6b: if explanted, give date: unknown; requested but not provided.; the extent of patient contact is unknown, however product was received indicating that the an explant was performed.The product was received for evaluation: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 31, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens had a cut down the middle, and scratches on the surface of the lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient experienced a myopic surprise following implantation of a single-piece preloaded toric intraocular lens (iol) in the dominant eye.The physician stated that a non johnson & johnson iol had been implanted in the patient¿s first eye several years earlier.Postoperatively, the patient expressed dissatisfaction with the surgical outcome.However, the patient reportedly understood that the event was not related to the lens type but rather to individual healing response.The physician scheduled an iol exchange to address the issue.Additional information indicated that the product was returned and investigated indicating that the explant was performed.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 25034402
• Report Number: 3012236936-2026-000094
• Device Sequence Number: 9175739
• Product Code: MJP
• UDI-Device Identifier: 05050474747753
• UDI-Public: (01)05050474747753(17)280523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: DIU300
• Device Catalogue Number: DIU300U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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 Sex: Male