MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS IOL; Lens, Intraocular, Toric Optics

Model Number	DIU450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal toric intraocular lens (iol) was fully implanted in the patient's right eye.During a postoperative examination, the lens was observed to be slightly inferiorly subluxated.The patient reported a sudden onset of decreased vision in the affected eye, with symptoms persisting for approximately six months.The lens was subsequently explanted during a secondary surgical procedure.A non-preloaded johnson & johnson ar40e lens of 20.5 diopter was implanted using the yamane technique.No delay in the procedure was reported.No unplanned incision enlargement, vitrectomy, or sutures were required.According to the information provided, the reported vitrectomy was planned.The patient was reported to have fully recovered following the intervention.It is unknown whether the reported symptoms impacted the patient's daily activities.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between may 31, 2022 and apr 29, 2026.Section h6: health effect - clinical code: 4581 - this code was used for the reported device decentered or dislocated or tilted subluxated or wrong position.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified, and the reported complaint issue could not be confirmed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• 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 ; +1(714)247-8552
• MDR Report Key: 50510067
• Report Number: 3012236936-2026-000253
• Device Sequence Number: 16121859
• Product Code: MJP
• UDI-Device Identifier: 05050474748897
• UDI-Public: (01)05050474748897(17)241026
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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 Expiration Date: 10/26/2024
• Device Model Number: DIU450
• Device Catalogue Number: DIU450U195
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/29/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: 82 YR
• Patient Sex: Female