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	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: n/a (not applicable).The intraocular lens was not implanted.If explanted, give date: n/a (not applicable).The intraocular lens was not implanted.Therefore, lens was not explanted.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the customer that the intraocular lens (iol) was damaged, defective.There was no patient contact with the product.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review of section e in follow-up 1, the country was inadvertently selected as united states, however, the country should have been canada.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Corrected data: in the initial report section g1, the zip code was inadvertently not entered.The zip code is (b)(6).Device evaluation: product testing could not be performed, since the product was not returned for evaluation.Therefore, the reported issue could not be verified.And product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.There are no discrepancies found, during the mrr (manufacturing record review).The search revealed, one complaint from this production order number.However the reported issue is unrelated to this reported complaint.And no product deficiency was identified in that case.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: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco
• MDR Report Key: 11141814
• Report Number: 2648035-2021-07051
• Device Sequence Number: 16315862
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)230812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 08/12/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021; 03/08/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/24/2021; 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1