MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SIGNATURE PACK, DISPOSABLE TUBING; PHACO TUBING

Lot Number UNKNOWN

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that cataract patients presented with toxic anterior segment syndrome (tass) after using phaco handpiece and signature disposable tubing packs.A brief description from the surgery center indicated that they have had four cases of tass.Attempts at follow up have been unsuccessful and no additional information is available at the time of this report.This report is for the tubing pack used for the 2nd unidentified patient.A separate report is being submitted for the handpiece used for the patient.Also separate reports for the handpiece and signature tubing packs will be submitted for the other 3 unidentified patients.

Manufacturer Narrative

B5: additional information.Patient outcome: all patients recovering with no clinically significant vision loss from the event.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• Type of Device: PHACO TUBING
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10928676
• MDR Text Key: 218986762
• Report Number: 3006695864-2020-00525
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPACT INTUITIV PHACO SYSTEM, SN UNKNOWN.; COMPACT INTUITIV PHACO SYSTEM, SN UNKNOWN
• Patient Outcome(s): Other