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

Model Number	DIB00
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b3: date of event: exact date unknown/not provided.Provided as on 4/17/2024, however, also provided as on 1/28/2025.Best estimate date is between 4/17/2024-1/28/2025.Section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.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.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during handling/prior to insertion a preloaded monofocal intraocular lens (iol) was scratched.There was no patient contact.Through follow up, it was learned that there was major resistance while inserting, so the surgeon aborted and saw a scratch on the lens.No further information was provided.
Additional Manufacturer Narrative
Additional info: 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 handpiece and lens was received loose inside the original folding carton.Visual inspection under magnification reveal the complaint handpiece was received with the plunger rod advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge.The cartridge tip was observed to be bent; stress marks were also observed on the cartridge tip but were in specification for a used device.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.Plunger rod advancement was inspected revealing no issues; the plunger rod tip was bent.The lens was observed to be coated in viscoelastic residue.The lens was cleaned and inspected revealing a haptic was detached and the lens was damaged and scratched.The complaint issue "difficult to use" could not be confirmed during product evaluation.The complaint issue "cosmetic issues" was 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, and the reported issue could not be all pertinent information available to johnson and 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: 21454511
• Report Number: 3012236936-2025-000050
• Device Sequence Number: 4528372
• Product Code: HQL
• UDI-Device Identifier: 05050474731615
• UDI-Public: (01)05050474731615(17)270417
• 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): 06/16/2025

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: DIB00U0130
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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: Female