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

Model Number ZCT100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information: breakdown of 3 event is as follows: cosmetic issues: 3.(udi#): only a portion of the udi is provided.Serial number of the suspect product: (b)(4).2 investigation were completed, and 1 investigations are pending from this period.Breakdown of 2 completed investigations: (b)(4): no product returned.(b)(4): no product returned.The investigation concluded that the product met manufacturing release criteria.A review of the records related to the device including complaint trend and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained then a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

This report summarizes 3 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.

Manufacturer Narrative

There is 1 investigation completed, during this period.Breakdown of 1 completed investigation: (b)(4), no product returned.The investigations concluded, that product met manufacturing release criteria and no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.That was received, during the time period that covers this voluntary malfunction summary report has been submitted.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11256456
• MDR Text Key: 242016993
• Report Number: 2648035-2021-00019
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ZCT100
• Patient Sequence Number: 1