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

Model Number HEALON 0.85

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

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.(b)(6).It was indicated that neither the device or the foreign material are returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information 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 vial of viscoelastic healon contained a black strand.There was no patient injury.Reportedly, the issue was noted during surgery, the hair-like material was injected into the patient's eye with the healon.The procedure was completed successfully.Neither the vial or the foreign material are available for inspection.The same issue was reported on two (2) vials, therefore 2 mdrs will be submitted.This is the second of 2 reports.

• Brand Name: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7528299
• MDR Text Key: 109110425
• Report Number: 3004750704-2018-00035
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 15050474500072
• UDI-Public: (01)15050474500072(17)201031(10)UC31977
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10200012
• Device Lot Number: UC31977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1