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

Model Number PCB00

Device Problem Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The intraocular lens was removed and replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after the implantation of the intraocular lens (model pcb00 +22.5 diopter), two (2) indentations were noticed on the lens.The lens was removed within 1 minute of implantation; the surgeon did not wait any longer to see if the indentations would disappear.Another lens was implanted as a replacement.It was noted that there was no impact to the patient.Adequate viscoelastic was used when preparing the lens for injection.No additional information provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 8/10/2018.Device returned to manufacturer? yes.Device evaluation: the lens was returned and evaluated.There was only a half of the lens received inside a tube.The delivery system was not received.Viscoelastic residue was observed on the lens.The condition in which the lens was received is consistent with a product that was implanted and removed.The reported complaint and deficiency could not be identified since only half of the lens was received.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.; santa ana CA 92705
• MDR Report Key: 7650004
• MDR Text Key: 112722140
• Report Number: 2648035-2018-00926
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558311
• UDI-Public: (01)05050474558311(17)210110
• 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
• Report Date: 01/01/2005,10/04/2018

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: Physician
• Device Expiration Date: 01/10/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1