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

Model Number	DIU225
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) had loading issue and the haptic was bent/broken.There was no patient contact.No further information was provided.
Additional Manufacturer Narrative
Patient information: not applicable, as there was no patient contact with the product.If implanted, give date: not applicable, as there was no patient contact with the product.If explanted, give date: not applicable, as there was no patient contact with the product.Reporter name (first and last): unknown/not provided.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 the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received from the product sticker label received along with the device revealed following information: correction: section b3: date of event: the correct date of event was (b)(6) 2022, and not (b)(6) 2022 as submitted in the initial report.Section b5: the right eye was the patient's operative eye.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jul 22, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint lens was stuck inside of the cartridge, near the lens module and was overridden by the plunger rod.The handpiece was disassembled and the assembly was inspected, revealing no assembly issues that could have contributed to the observed issues.The lens was removed from the cartridge and cleaned, revealing that it was torn and damaged in a way consistent with a lens that was folded inside of the cartridge.Conclusion: the reported complaint issues were not confirmed.Any additional issues observed during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.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: 14990913
• Report Number: 3012236936-2022-01833
• Device Sequence Number: 13891560
• Product Code: MJP
• UDI-Device Identifier: 05050474746886
• UDI-Public: (01)05050474746886(17)240129
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 01/29/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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: Unknown