MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON PRO; OVDS

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Lot number: unknown, information not provided.Unique device identifier (udi #): unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.If implanted, if explanted, give date: not applicable, the healon is not an implanted product.(b)(6).(b)(4).The device was not returned for analysis; it was discarded.There was no lot number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a fibrous material came out in the patient eye.Reportedly, the foreign material was removed with ia (irrigation/aspiration) procedure and no other treatment was required.Doctor experienced the same issue a few times.No patient injury.No further information was provided.This is one of two reports.

Manufacturer Narrative

Additional information: a video/film and recovered fiber was received from the account and the issue was confirmed.The fiber had been placed into a small plastic jar in a clear solution with a white screw-cap.This fiber was found to be 4.93 mm long.The visual analysis of the recovered fiber indicated that it was a colorless, cellulose fiber that had expelled from the cannula into the patient¿s eye.As neither the complaint cannula or syringe was returned for inspection, then no definite conclusion can be made as to the root-cause of this issue.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

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 (b)(4).

• Brand Name: HEALON PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8533810
• MDR Text Key: 147612202
• Report Number: 3004750704-2019-00009
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TH85ML
• Device Catalogue Number: TH85ML
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1