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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6a date implanted: unknown/asked information was not provided.Section d-6b date explanted: unknown/asked information was not provided.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint; however, to date no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During the procedure, the dib00 model intraocular lens (iol) fell into the back of the patient's eye, requiring an anterior vitrectomy.A lens defect was also reported.The procedure was completed using a new lens; however, it was also reported the iol is still in the patient's eye.Patient prognosis post-procedure is unknown.No further information is available.
Additional Manufacturer Narrative
Correction: upon further review, it was noted that lens damage - device code: 1069 reported in the initial mdr was incorrect and no reported device problem - device code: 2993 was more appropriate.Iol removal and replacement and device decentered/dislocated codes were also found to be appropriate for the complaint.Additional information: additional information was received confirming the iol was fully inserted and the vitrectomy was unplanned.There was no incision enlargement, no sutures, and the same procedure was completed using a non-johnson & johnson surgical vision lens, ma60ac, that was implanted in the patient¿s ocular dexter (right eye).There was no product quality issue that contributed to the event.No further information is available.The corrected information is captured in this supplemental report.The following fields were updated accordingly: section a-3b: patient gender: male.Section a-4: patient weight: 195 lbs.Section h-6: health effect - device code: 2993 - no reported device problem.Section h-6: health effect - impact code: 4631 - iol removal and replacement.Section h-6: health effect - clinical code: 4581 - device decentered/dislocated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 23900982
• Report Number: 3012236936-2025-000344
• Device Sequence Number: 13290956
• Product Code: HQL
• UDI-Device Identifier: 05050474731615
• UDI-Public: (01)05050474731615(17)280403
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0130
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 88 KG