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

Model Number PCB00

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The lens was not implanted.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a tecnis itec preloaded intraocular lens (iol) came out of inserter too quickly during insertion.It was noted only the inserter tip touched the patient's eye.A different lens was used to complete the procedure.The patient was reported to be doing fine post-surgery.The customer indicated that the lens was disposed, and only the inserter is available for return.No further information provided.

Manufacturer Narrative

Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 11/5/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the pcb00 product was returned in its original package.Visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position.Residues of lubricant material was observed on cartridge.No damaged was observed to the cartridge.The lens was observed stuck in cartridge and the leading haptic was observed not folded.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported 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 of complaints revealed no additional complaint folders have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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: 10709462
• MDR Text Key: 212268323
• Report Number: 2648035-2020-00768
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)220820
• Combination Product (y/n): Y
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR