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

Model Number	PCB00
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
Weight and ethnicity: unknown/ not provided.Date of event: unknown, not provided.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.Telephone number: (b)(6).Device evaluation: product evaluation could not be performed since at the time of this investigation, the product had not been received.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported from a customer fax, "defective loop." it was reported that a patient was involved.No other information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer on: 6/28/2021 device evaluation: the preloaded unit was returned for evaluation.The product was returned in its original packaging with sheet labels, implant card and dfu.Upon evaluation of the device all the components were correctly engaged, and pushrod was in a partially advanced position.No assembly error and/or defect related to manufacturing process was observed.Lubricant material residues were observed in the cartridge tip and in the lens storage zone.The lens was received out of the device, wrapped in a gauze and with both haptics detached.Therefore, the reported issue was not verified.Due to the condition of the sample returned product quality deficiency could not be determined.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12055423
• Report Number: 2648035-2021-07938
• Device Sequence Number: 3979715
• Product Code: HQL
• UDI-Device Identifier: 05050474558373
• UDI-Public: (01)05050474558373(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 11/30/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1