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

Model Number PCB00

Device Problems Break (1069); Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown as information was not provided.If implanted, give date: not applicable as the iol was not implanted.If explanted, give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the lens was damaged and shooter would not work.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.No further information is available.

Manufacturer Narrative

Device evaluation: product testing could not be performed, because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed, that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 PR 00610
• MDR Report Key: 11286191
• MDR Text Key: 233272017
• Report Number: 2648035-2021-07212
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)230225
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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: 02/25/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1