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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an intraocular lens (iol) had a defective loader/injector, damaged lens, and was identified during the handling of the lens.There was no patient contact.Through follow up, it was learned that the lens was stuck in the injector and would not come out.The surgeon did not want to use force as there was resistance.So, the surgeon ended up opening another lens.There was a 2 minute delay in procedure.The surgeon did not have to enlarge the wound.There were no complications.There were no issues post-operative (op).Patient had no negative consequences.No other details are available.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: not applicable, as there was no patient involvement.Section d6a: if implanted, give date: not applicable, as there was no patient involvement.Section d6b: if explanted, give date: not applicable, as there was no patient involvement.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, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 3/27/2025.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint product was received on the handpiece tray.Visual inspection under magnification revealed the handpiece was received with the plunger rod advanced to the lens stuck in the cartridge tube.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge indicating an inadequate amount of ovd may have been used which could contribute to the complaint issue reported.The cartridge tip was observed to be deformed.The lens module was inspected revealing no issues or viscoelastic residue.Device assembly was inspected revealing no issues.The plunger rod and plunger rod advancement was inspected revealing no issues.The lens could not be removed from the cartridge for evaluation; however the lens was observed to be crumpled in the cartridge tube.No further evaluation was performed.The complaint issue "difficult to use" was not identified during product evaluation; however, "lens damaged" and "stuck in cartridge" were identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency or product malfunction.

• 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: 21464965
• Report Number: 3012236936-2025-000055
• Device Sequence Number: 3568064
• Product Code: HQL
• UDI-Device Identifier: 05050474731837
• UDI-Public: (01)05050474731837(17)270828
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: DIB00U0235
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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: Unknown