MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION INC. TECNIS 1 ASPHERIC IOL, ITEC PRELOADED DELIVERY SYSTEM (INTRAOCULAR LENS)

Catalog Number CE 0344

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

The patient presented to the hospital on (b)(6) 2021 related to a visually significant cataract of the right eye for a procedure of phacoemulsification of cataract with insertion of intraocular lens.The documentation revealed as the physician tried to inject the lens, she was unable to because the plunger was on top of the lens instead of behind it.The device was wasted and a new replacement lens was used on the patient with no reported injuries.Fda safety report id # (b)(4).

• Brand Name: TECNIS 1 ASPHERIC IOL, ITEC PRELOADED DELIVERY SYSTEM (INTRAOCULAR LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION INC. ; santa ana CA 92705
• MDR Report Key: 11372270
• MDR Text Key: 233556400
• Report Number: MW5099580
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Catalogue Number: CE 0344
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 82