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	Visual Disturbances (2140)
Date of Event	12/01/2025
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 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 will be filed.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 after the preloaded monofocal intraocular lens (iol) was implanted into the patient's right eye, the patient was unable to adapt to the lens and near target.The lens was subsequently explanted during a secondary surgery and replaced with another johnson and johnson iol of the same model with +10.5 diopter.The issue was first observed during a post-operative examination and persisted for approximately two months and three weeks.No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy were required.It was unknown if there were any surgical delays or medication prescribed that was outside of the standard of care.Directions for use was followed.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Device evaluation: visual inspection revealed the lens was received cut in half.During the product evaluation it was confirmed that the physical characteristics of the lens matched a dib00 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The ¿lens cut¿ observed during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes section d9: date returned to manufacturer: jan 7, 2026 section h3: device evaluated by manufacturer: yes.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: 24032866
• Report Number: 3012236936-2026-000007
• Device Sequence Number: 15768104
• Product Code: HQL
• UDI-Device Identifier: 05050474731622
• UDI-Public: (01)05050474731622(17)280415
• 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: 2025
• Device Explanted Year: 2025
• 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): 02/17/2026

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: DIB00U0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: 68 YR
• Patient Sex: Female