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

Model Number	DIB00
Medical Device Problem Codes	Mechanical Jam (2983); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/not provided.Section d6a: if implanted, give date: unknown/not provided; reported as both partial insertion and lens inserted and removed during same procedure.Section d6b: if explanted, give date: unknown/not provided; reported as both partial insertion and lens inserted and removed during same procedure.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, no definitive response has been received.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) got stuck at the tip of the cartridge.The lens was partially inserted.It was also reported the lens was inserted in the patient's right eye and removed during the same procedure.The patient fully recovered.The directions for use were followed, and there was a delay in the procedure, but no additional medical intervention was required outside of standard care.There were no vitrectomy, incision enlargement, or sutures required.No other information was provided.
Additional Manufacturer Narrative
Additional info: further information was provided and clarified that the lens was partially inserted.It was unknown if there was patient injury.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.The product was discarded.No other information was provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed one similar complaint for this production order number and although the complaint issue reported is related, the issue could not be confirmed as related to manufacturing.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Corrected data: the following section has been updated accordingly: section h6: health effect - impact code: the code provided in the initial report 4627 is no longer applicable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in reviewing the file, it was determined that the reported delivery issue no longer meets the reporting criteria for a reportable malfunction.It was clarified that the lens was not fully inserted in the patient's right eye as it was partially inserted and removed during the same procedure.Therefore, this event is no longer considered a reportable malfunction as there was no report of additional surgical maneuvers.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: 24492198
• Report Number: 3012236936-2026-000057
• Device Sequence Number: 17416190
• Product Code: HQL
• UDI-Device Identifier: 05050474731493
• UDI-Public: (01)05050474731493(17)270629
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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: DIB00U0070
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 05/28/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/11/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2024
• 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 Age: 56 YR
• Patient Sex: Female