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

Model Number	DIU150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the diu150 intraocular lens back haptic got bent during handling before patient contact.The inner pouch was not opened/un-sealed when received.Additional information revealed that the procedure was completed successfully using another diu150 lens.There was no use error during handling.No other information is available.
Additional Manufacturer Narrative
Section a4: patient weight: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section h3: 81: the device was not returned for evaluation as the lens remain implanted in the eye.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 6/12/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received stuck inside of the cartridge.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint or observed issue could be identified.The lens was removed from the cartridge and cleaned, revealing that the lens was damaged and had a detached haptic.Conclusion: the complaint issue haptic damage was not identified during photo and product evaluation.The observed haptic detached is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.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: 17144958
• Report Number: 3012236936-2023-01491
• Device Sequence Number: 12205413
• Product Code: MJP
• UDI-Device Identifier: 05050474746527
• UDI-Public: (01)05050474746527(17)251017
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/19/2023

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: 10/17/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U190
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/09/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White