MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

If explanted; give date: not applicable, lens remains implanted.Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that upon injecting the lens into the eye, the surgeon noted a small fragment of plastic.Irrigation/aspiration (i/a) was performed and the surgeon was confident that the fragment was removed.There was no incision enlargement, no vitrectomy and no sutures required.There was no medication prescribed.The patient's status is unknown.No further information was provided.

Manufacturer Narrative

Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 2/15/2021.Device evaluation: complaint product was received at manufacturing site.Upon evaluation of the plunger, it was observed to be in a fully advance position.The tip of the pushrod was bent that could be related to the use of excessive force during handling.Product was carefully reviewed but not signs of foreign material could be identified.No lens was returned for evaluation.Also, since the particle was not provided, an analysis of composition identification cannot be performed.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: the product testing could not be performed, as the product remains implanted.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed, no additional/ no similar complaint folder has been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality 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 ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10840959
• MDR Text Key: 260978183
• Report Number: 2648035-2020-00856
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474619944
• UDI-Public: (01)05050474619944(17)230608
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB000A220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR