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

Model Number	DIB00
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown/ not provided.Date of event: unknown, not provided.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.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 an intraocular lens (iol) had a fiber wrapped around it and there was patient contact with the fiber and lens.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: 10/4/2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed the alleged foreign material was received in a specimen cup, which was then sent to eag laboratories for further analysis.A material analysis report was requested for the foreign material, and the product was received by eag laboratories.Per eag laboratories, ftir analysis indicates that the foreign material is consistent with a protein-based fiber (e.G., hair/fur, silk or wool).The ftir spectrum raw data output file generated by eag laboratories was then compared against the añasco manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The top hit was ¿n/a1pc aluminum plate¿ with a 0.267232 correlation.The complaint issue was confirmed, however based on the ftir result the foreign material is not part of the device components.However, the origin of the alleged foreign material cannot be determined to be part of manufacturing process and is therefore inconclusive.Throughout the manufacturing processes there are various cleaning operations and 100% visual inspection utilizing microscope magnification steps that would have identified and discarded a lens with a similar particulate or substance as required by our approved procedures.The manufacturing process is performed inside a regulated clean room class 6 manufacturing room that requires full gowning before entering the room.No product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12536967
• Report Number: 2020664-2021-07538
• Device Sequence Number: 1428870
• Product Code: HQL
• UDI-Device Identifier: 05050474731851
• UDI-Public: (01)05050474731851(17)240625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

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 Expiration Date: 06/25/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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