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

Model Number	DIU600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h6: health effect impact code: 4631 (to capture pt-removal and replacement).Section h3-other (81): 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.An attempt has 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) was fully inserted in the patient's right eye, but was removed and replaced in the same procedure due to defect on lens.The back-up iol with same model and diopter power was implanted instead.Normal post-op course.One suture was performed which the doctor does in all his iol exchanges.Patient is happy with his vision.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: 9/21/2023 section h3.Device evaluated manufacturer? yes device evaluation: visual inspection revealed that the complaint handpiece was received with the plunger rod advanced to the cartridge.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The complaint cartridge was inspected revealing that viscoelastic residue was not dispersed throughout the length of the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint issue.Visual inspection of the complaint lens revealed that the lens was received cut in half.The lens was cleaned and, no defects on the lens could be observed.The complaint issue of ¿dc-lens damaged¿ was not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17703530
• Report Number: 3012236936-2023-02313
• Device Sequence Number: 15133277
• Product Code: MJP
• UDI-Device Identifier: 05050474749979
• UDI-Public: (01)05050474749979(17)241210
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 12/10/2024
• Device Model Number: DIU600
• Device Catalogue Number: DIU600U145
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White