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

Model Number TG85ML

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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).Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that two similar complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when aspirating healonpro gv, the tubing of a non-johnson & johnson phaco machine clogged.Reflux and rinse or handle exchange were all unsuccessful.Also, the increase in suction power brought no improvement.Replacement of the tubing system brought improvement.Patient had increased intraocular pressure the next day and had to be treated for it.The material was discarded.Through follow-up we learned that the anterior chamber was cleared without issues and the patient outcome was as expected.No additional information was provided.

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 GV 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: 9248474
• MDR Text Key: 166987416
• Report Number: 3004750704-2019-00051
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651593
• UDI-Public: (01)05050474651593(17)220430(10)UE31283
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: TG85ML
• Device Lot Number: UE31283
• 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
• Patient Outcome(s): Required Intervention