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

Model Number ZCB00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Disturbances (2140); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided, best estimate is between (b)(6) 2019.Unknown/not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was explanted from the patient's right eye, due to the patient experiencing visual disturbances.Reportedly, the incision was enlarged, however, the patient has recovered.The lens was replaced with the a different model, and diopter iol.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional information: device available for evaluation; returned to manufacturer on: 6/12/2019.Device evaluation: the lens was observed cut in a half which could be related to handling during the removal process.Loose particles were observed on the lens surface.Due to the condition in which the sample was returned the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no additional complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-(b)(4) and capa-010215.

• Brand Name: TECNIS 1-PIECE
• 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: 8641033
• MDR Text Key: 146120354
• Report Number: 2648035-2019-00600
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)220220
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/18/2019; 10/25/2020
• Supplement Dates FDA Received: 07/17/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention