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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded monofocal intraocular lens (iol), model dib00, was removed after it was placed in the patient's left eye due to a tear in the capsular bag and not due to a damage in the lens.There were unplanned vitrectomy and sutures required.For sutures, it was the doctor's standard practice.Miostat was given as medication outside the standard of care.Replacement used was of non-johnson and johnson lens (alcon).Patient outcome and post-operative refraction with the new replacement lens was indicated as defer to the surgeon.The complaint device was discarded.No additional information was provided.
Additional Manufacturer Narrative
Section a4: weight: the weight of 88.5 kilograms did not populate in the field because the system does not accept decimal values.Section d6a: not applicable, as the lens was inserted and removed in the same procedure.Section d6b: not applicable, as the lens was inserted and removed in the same procedure.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 records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed no other complaints were received for this production order number.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Section h6: health effect- impact code 4625:additional surgery- unplanned vitrectomy : surgical intervention and sutures : surgical intervention.All pertinent information available to johnson & 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: 25144455
• Report Number: 3012236936-2026-000129
• Device Sequence Number: 9454651
• Product Code: HQL
• UDI-Device Identifier: 05050474731806
• UDI-Public: (01)05050474731806(17)281223
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: DIB00
• Device Catalogue Number: DIB00U0220
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2025
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White