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

Model Number HEALON 0.55

Device Problem Separation Problem (4043)

Patient Problem Capsular Bag Tear (2639)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when the surgeon engaged, pulled out the healon plunger during retraction, the healon cannula shot off into the patient's eye and the force led to tear in the capsule.Reportedly, this altered the surgical plan of relaxing cut 90° away, iol sulcus optic capsule healon to maintain during changes and miostat was used.It was indicated that the surgery completed successfully and that the patient outcome is within the normal limits.No further information was provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the device was not returned for evaluation.The reported complaint could not be verified.Manufacturing records review: the manufacturing records for the device were reviewed and no deviation was found.The product was manufactured and released according to specification.A search in complaint system revealed that no similar complaints have been received for this batch.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 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
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8537686
• MDR Text Key: 142723806
• Report Number: 3004750704-2019-00011
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474636972
• UDI-Public: (01)05050474636972(17)210831(10)UD31689
• 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,health
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: HEALON 0.55
• Device Catalogue Number: 10295210
• Device Lot Number: UD31689
• 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: 03/25/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 07/10/2019; 10/25/2020
• Supplement Dates FDA Received: 08/05/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR