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 Patient Involvement (2645)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) of the tecnis itec preloaded device was cracked in the injector (insertor).There is no indication of patient contact with the lens.No additional provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 1/28/2021.Section h3: device returned to manufacturer? yes.Device evaluation: visual inspection revealed no damages to the lens nor preloaded device.The preloaded device was observed, with the pushrod in a fully advanced position, with viscoelastic residues at the cartridge tip.Based on the return condition of the lens, the complaint reported was not verified.There was no product deficiency identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed, no additional complaint folder has been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & 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
• MDR Report Key: 11143950
• Report Number: 2648035-2021-07060
• Device Sequence Number: 18990552
• Product Code: HQL
• UDI-Device Identifier: 05050474558441
• UDI-Public: (01)05050474558441(17)230407
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 04/07/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1