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

Model Number	DIU300
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or dob, weight, ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during 2021.If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that two preloaded intraocular lenses (iols) were sterile compromised as the packaging was not fully intact.One of the lens package had a little hole by the knob and the other was completely ripped at the fold by the knob.The devices were not damaged.However, one box looked like it might have been damaged during shipping, but the serial number of the box could not be confirmed.There was no patient contact with the lenses.Through follow-up, it was clarified that the sterile pouch was damaged on both iols.The box was damaged on just one of the lens.No further information was available.This report captures one of the lens and a separate report is being submitted for the other lens.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 11/10/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Sample was received in its folding carton package with labels patient card and implant card.Folding carton box was observed damage/broken.A puncture was observed in the sealed pouch containing the complaint handpiece and iol.The complaint issue was confirmed, however the complaint issue was further investigated by añasco manufacturing sme, who determined that based on the return condition of the product it is possible that these boxes and pouches were damaged and broken during shipping, and therefore cannot be confirmed to be related to manufacturing and no product deficiency could be identified.There is no information of the shipping box and if it was damaged during shipment by the carrier.Based on the incomplete information, no device code investigation can be performed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12545007
• Report Number: 2020664-2021-07556
• Device Sequence Number: 4031972
• Product Code: MJP
• UDI-Device Identifier: 05050474747609
• UDI-Public: (01)05050474747609(17)240718
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/16/2021

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: 07/18/2024
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2021
• 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