MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC.; PHACO ACCESSORY

Lot Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown as it was not provided.Brand name is unknown as it was not provided.Model no.Is unknown as it was not provided.Lot no.Is unknown as it was not provided.Unique identifier (udi#) is unknown as lot no.Was not provided.Name is unknown.Telephone: (b)(6).Manufacturer date is unknown as lot no was not provided.Device evaluation: the product was not returned.The complaint cannot be confirmed manufacturing record review: a review of the manufacturing records could not be performed as a product lot number was not provided.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract procedure, the surgery center experienced a loose connection between tip and hand piece.It is unknown if the tip was in the eye when the error occurred.There was no patient injury.

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 (b)(4) and capa-010215.

• Type of Device: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9522273
• MDR Text Key: 183515632
• Report Number: 3006695864-2019-01013
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• 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: 11/26/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1