MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem Eye Injury (1845)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

Injector had a barb on it which caused a tear in the patient's eye that required a suture to repair.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10430590
• MDR Text Key: 203680987
• Report Number: 10430590
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2020,06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE08507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA