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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Misassembled (1398); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded monofocal intraocular lens (iol) was incorrectly positioned in the chamber and appeared twisted.The issue was observed during handling before patient contact.The procedure was completed with a backup lens of the same model and diopter.Additional information was received and it was learnt that lens was stuck in cartridge.The healon duo visc and bss (balanced salt solution) from johnson & johnson were used.No additional information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 & a6: not applicable, as there was no patient contact with the device section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Date returned to manufacturer: nov.5, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the lens was overridden by the plunger rod inside the cartridge, however the lens was not stuck in the cartridge.The cartridge tip was observed to be damaged.Ovd was observed inside the cartridge.No issues were identified on the lens module, plunger rod, and handpiece.The lens was removed from the cartridge and was observed to be coated on viscoelastic residue.The lens was cleaned and inspected and no issues were identified.The complaint 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: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.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: 23286552
• Report Number: 3012236936-2025-000264
• Device Sequence Number: 8854109
• Product Code: HQL
• UDI-Device Identifier: 05050474731639
• UDI-Public: (01)05050474731639(17)270813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: DIB00U0140
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON DUO VISC AND J & J BSS.
• Patient Sex: Unknown