MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SIMPLICITY DELIVERY SYSTEM 1 PIECE IOL; INTRAOCULAR LENS

Catalog Number DCB00

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

The patient presented to the hospital with a visually significant cataract of the left eye and underwent procedure of "complex phacoemulsification of cataract with insertion of intraocular lens." documentation by the internal report revealed a pre-loaded intraocular lens was injected into the capsular bag and the lens was rotated into position using the kuglen hook.However, a previous pre-loaded lens device had the plunger that went over the lens during advancement through the inserter before the successful lens injected.No other complications were reported, or information given about the device failure.No patient injury reported.Fda safety report id # (b)(4).

• Brand Name: TECNIS SIMPLICITY DELIVERY SYSTEM 1 PIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 11700423
• MDR Text Key: 247004962
• Report Number: MW5100881
• Device Sequence Number: 1
• Product Code: HQL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2021

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 Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Catalogue Number: DCB00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 142