MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number ZCB00

Device Problem Torn Material (3024)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the intraocular lens (iol) was damaged/torn during injection.The iol unfolded incorrectly.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 05/2/2018.Device returned to manufacturer? yes.Device evaluation: the product was received in a biohazard bag and was inspected by a qualified inspector using a 12x magnification.It showed some traces of ophthalmic viscosurgical devices (ovd) on both sides of the lens surface.The traces of ovd can be removed and the lens was re-inspect again.Visual inspection of the cleaned lens shows scratches on the optic area at anterior side.However, how and when the scratched happened could not be determined.Lens was further measured.All dimensional measurements of returned sample (haptic width, optic diameter, overall diameter and haptic thickness) were within specification.The complaint on lens damaged, iol torn and unfolding issue cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no other complaint was received from 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: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7451699
• MDR Text Key: 106249323
• Report Number: 3011852734-2018-00056
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)211028
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/28/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1