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

Model Number PCB00

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

Event Type  malfunction  

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 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.

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.

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco
• MDR Report Key: 11141814
• MDR Text Key: 234037812
• Report Number: 2648035-2021-07051
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)230812
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1