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

Model Number ZCU

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.Date of event: unknown, not provided; best estimate is sometime before 3/17/2020.Model# and catalog#: a complete model and catalog number are unknown, as serial number was not provided.Serial number: unknown, information not provided.Unique device identifier (udi #): unknown, as serial number was not provided.Expiration date: unknown, as serial number was not provided.If implanted; give date: unknown/not provided.If explanted; give date: not applicable lens remains implanted.The device was not returned for analysis as the lens remains implanted.There was no model/serial number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown as serial number was not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported that a tecnis toric zcu intraocular lens (iol) did not rotate after initial implantation, and the surgeon had to bring the patient back to surgery and rotate the lens 40 degrees.Through follow up, the surgeon indicated that the patient was post lasik, the lens was in the correct orientation per pre-op calculation done with two lenstar, nidek opd topography and zeiss topography, measurements all confirmed and agreed.The lens rotated easily, 30-35 degrees clockwise.There was no additional surgical intervention performed.The lens remains implanted and the patient understood possibility of post refractive surprise and is not unhappy.No further information was provided.

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-0148919 and capa-010215.

• Brand Name: TECNIS TORIC
• 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: 9955085
• MDR Text Key: 192008872
• Report Number: 9614546-2020-00188
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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
• Report Date: 01/01/2005,10/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCU
• Device Catalogue Number: ZCU
• Was Device Available for Evaluation?: No
• 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: 03/17/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention