MAUDE Adverse Event Report: JOHNSON JOHNSON SURGICAL VISION, INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DCB00

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Lens was loaded backwards.Deployed upside down.Has been reported to mfg, rga# (b)(4).

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 16303085
• MDR Text Key: 308830441
• Report Number: 16303085
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female