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

Model Number PCB00

Device Problems Material Fragmentation (1261); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown/ not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an preloaded device (pcb00) had plunger rod issue and haptic detached.There was no patient contact with the product.No further information provided.

Manufacturer Narrative

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 record evaluation: the manufacturing records for the device 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.All pertinent information available to johnson and 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 PR 00610
• MDR Report Key: 11203032
• MDR Text Key: 244162793
• Report Number: 2648035-2021-07124
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)231017
• 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
• Report Date: 04/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1