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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: not applicable as there was no patient contact with the device.Section b-3: date of event: unknown as information was not provided.Section d-6a date implanted: not applicable as there was no patient contact with the device.Section d-6b date explanted: not applicable as there was no patient contact with the device, therefore not explanted.Section h3-81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the diu225 model intraocular lens (iol) was damaged inside the box but the box was not crushed; damage occurred in transit.There was no patient contact as the device never made it into the operating room.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 06-dec-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the device was received inside a sealed sterilization pouch.The handpiece was inspected under magnification.The handpiece was received inside a sealed sterilization pouch which was located inside the crushed original folding carton.The handpiece showed no damage.The cartridge was inspected from inside the sealed sterilization pouch and showed no damage.The lens was placed properly inside the lens module and showed no signs of damage.Complaint issue "lens damaged" was not identified during product evaluation.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 and the reported complaint issue could not be confirmed.No product deficiency or product malfunction was 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: 18223486
• Report Number: 3012236936-2023-03020
• Device Sequence Number: 6061403
• Product Code: MJP
• UDI-Device Identifier: 05050474747227
• UDI-Public: (01)05050474747227(17)241208
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 12/08/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U245
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 01/28/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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