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

Model Number ZCB00

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

No patient contact reported.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a hole was noticed in the intraocular lens zcb00 during handling but prior to insertion into the eye.No patient contact was reported.No additional information provided.

Manufacturer Narrative

Returned to manufacturer on: 6/8/2018.Device evaluation: the product was received for investigation.Visual inspection showed that the lens was returned in the daisy wheel with one of the haptics folded.The product was inspected by a qualified inspector using a 12x magnification, shows some traces of ophthalmic viscosurgical devices (ovd) on both sides of the lens surface with one side of the haptic folded.The lens was cleaned and haptic was unfolded.Visual inspection of the cleaned lens does not show a hole on the returned lens.However, few scratches were found at the optic area.The reported complaint could not 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, warnings, 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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; lot h.s (d) 70252, pt 2489; jalan hi tech 11, industrial z; kulim hi tech park 09000 ; MY 09000
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7555671
• MDR Text Key: 109625670
• Report Number: 3011852734-2018-00089
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531710
• UDI-Public: (01)05050474531710(17)220320
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/20/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1