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

Model Number HEALON 0.85

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a black material came out from healon ovd (ophthalmic viscosurgical device) into patient's eye.As a result, foreign material was removed with i/a (irrigation/aspiration).There was no incision enlargement, no vitrectomy, and no sutures used.Reportedly, there was no patient injury.No additional information provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.Since the lot number is unknown a visual inspection on retained products could not be performed.The reported complaint could not be verified.Manufacturing record review: manufacturing record review can not be performed since the lot number is unknown.Labeling review: the labeling review could not be performed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information 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
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8433243
• MDR Text Key: 139221792
• Report Number: 3004750704-2019-00003
• 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: 01/01/2005,11/10/2020

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 Model Number: HEALON 0.85
• Device Catalogue Number: UNKNOWN
• 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: 02/19/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 10/25/2020
• Supplement Dates FDA Received: 05/29/2019; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1