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

Model Number	HEALON 0.55
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8537686
• Report Number: 3004750704-2019-00011
• Device Sequence Number: 399811
• Product Code: LZP
• UDI-Device Identifier: 05050474636972
• UDI-Public: (01)05050474636972(17)210831(10)UD31689
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 10/25/2020
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 08/05/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005