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

Model Number ZCT150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information: breakdown of 2 events is as follows: cosmetic issues: 2.Unique identifier (udi#): only a portion of the udi is provided.Serial number of the suspect product: (b)(4): 1.(b)(4): 1.2 investigation were completed, and 0 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 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

This report summarizes (noe) 2 (/noe) malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11256524
• MDR Text Key: 244382147
• Report Number: 2648035-2021-00020
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/31/2021

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: ZCT150
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1