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

Model Number	DIU300
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was folding issue with an intraocular lens (iol) for a patient's left eye and the haptic was bent/broken.Injector went over, cut trailing haptic.The issue was noticed during handling prior to insertion and there was no patient contact with the device.The procedure was completed using another lens of the same model and diopter as the replacement for the patient¿s left eye.The product will not be returned as it was discarded.No further information will be provided.
Additional Manufacturer Narrative
Weight and ethnicity: not applicable, as there was no patient contact with the device.Implant date: if implanted, give date: not applicable, no patient contact with the device.Explant date: if explanted, give date: not applicable, no patient contact with the device.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 product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.Although the complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Therefore, no escalations are required.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 missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the code "4114" was inadvertently entered in the section "h6" of the initial mdr report instead of "4115" and it was also noted that section "h10 - device evaluation" in the initial mdr report inadvertently did not indicate that the device was discarded, which the information has been corrected in this supplemental mdr report.The following fields were updated accordingly: section h6: type of investigation: 4115.Device evaluation: the device was not returned for evaluation as it was discarded; therefore, product testing could not be performed, and the customer¿s reported complaint 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: 16423900
• Report Number: 3012236936-2023-00452
• Device Sequence Number: 17750501
• Product Code: MJP
• UDI-Device Identifier: 05050474747630
• UDI-Public: (01)05050474747630(17)240629
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 06/29/2024
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U155
• Was Device Available for Evaluation?: No
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: Male