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

Model Number	DIB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4: weight: unknown/asked but not provided.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, there is no additional information available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) haptics were sticking to the edge of the optic and a surgical tool was needed to separate the haptics.One of the haptics did not fold out properly, was still folded or was not fully deployed/unfolded.Therefore, the lens did not position properly in the patient's eye.The patient reported vision is good, 20/25, but occasionally sees a line, when looking into bright lights.The patient is not very bothered.However, the iol exchange was planned for (b)(6) 2025.The procedure involved a 10-minute delay.Through follow up, it was learned the iol exchange was performed on (b)(6) 2025.There was no vitrectomy, incision enlargement, or sutures required.There was no patient injury.Another johnson & johnson lens (same model and diopter) was successfully implanted as a replacement.The patient is doing well post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 2/4/2026.Section h3: device evaluated by manufacturer? yes.Device evaluation: a lens was received inside a specimen cup, in a plastic bag.Visual inspection under magnification was performed on the suspect product and found the lens was cut and coated in dried blood and viscoelastic residue.The lens was cleaned and inspected revealing damage on the surface of the lens and one detached haptic.No further issues were identified.No further evaluation was performed.The complaint issue "haptic stuck to optic", "instability of device after implantation" and "unfolding issues" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: 23560011
• Report Number: 3012236936-2025-000303
• Device Sequence Number: 10148891
• Product Code: HQL
• UDI-Device Identifier: 05050474731721
• UDI-Public: (01)05050474731721(17)270812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0185
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White