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

Model Number ZLU300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vitrectomy (2643)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

If implanted: not applicable as the iol was not implanted.If explanted: not applicable as the iol was not implanted.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was not implanted and an unplanned anterior vitrectomy was performed.No further information was provided.

Manufacturer Narrative

Additional information: device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS MULTIFOCAL TORIC II IOL
• 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: 10727465
• MDR Text Key: 212769525
• Report Number: 9614546-2020-00456
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474690554
• UDI-Public: (01)05050474690554(17)250313
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: ZLU300
• Device Catalogue Number: ZLU300U205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR