MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU225
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when inserting an intraocular lens (iol) into the patient¿s left eye, the lens did not deploy because the device tip was bent.The tip possibly touched the patient.Reportedly, this is not a stuck in cartridge issue.The issue is related to the bent tip.It came out of the package that way.The issue is not related to use error.The procedure was completed successfully with a backup iol.There were no complications such as incision enlargement, vitrectomy, or sutures.No further information was provided.
Additional Manufacturer Narrative
Weight and ethnicity: information unknown/not provided.Implant date, if implanted, give date: not applicable, as the device was not implanted.Explant date, if explanted, give date: not applicable, as the device was not implanted, therefore, not explanted.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 that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts have been made to obtain the missing information.However, to date it has not been received.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: date returned to manufacturer: dec 19, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint handpiece was received inside of the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge tip.The cartridge was cracked and damaged around the lens, the cartridge tip was cracked as well.The lens could be observed to be overridden by the plunger rod.The handpiece assembly was inspected and, no issues that could contribute to or cause the observed issue could be identified.A product quality deficiency could not be determined.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 IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15945268
• Report Number: 3012236936-2022-02856
• Device Sequence Number: 6442798
• Product Code: MJP
• UDI-Device Identifier: 05050474747050
• UDI-Public: (01)05050474747050(17)240217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/23/2023

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: 02/17/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U160
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: Female