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

Model Number	DIU225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after full implantation of the preloaded toric intraocular lens (iol) into the right eye, a defect was found on the lens.The lens was removed during the same procedure.Unplanned sutures and an unplanned incision enlargement was required.No vitrectomy was needed.There was a 45 minute delay in procedure.Directions for use were followed.No further information was provided.
Additional Manufacturer Narrative
Section a3b: gender: unknown; requested but not provided.Section a6: race: unknown; requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed during the same procedure.Section h3: 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 and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - clinical code 4581 is to capture incision enlarged.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: apr 29, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the plunger rod was fully advanced, and the plunger rod tip was damaged consistent with damage that occurs during shipping.The lens module was opened, and no damage or viscoelastic residue was identified.Device assembly was inspected, presenting with no issues.No lens was received.The complaint issue was not identified during product evaluation.The other observed issues 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.Conclusion: based on the complaint investigation results, the product was released within specifications.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: 19282996
• Report Number: 3012236936-2024-000135
• Device Sequence Number: 15190897
• Product Code: MJP
• UDI-Device Identifier: 05050474747128
• UDI-Public: (01)05050474747128(17)250808
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/04/2024

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: 08/08/2025
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U195
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic