MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number HEALON 5

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, not provided.Expiration date and unique identifier (udi#): unknown, because the lot number was not provided.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).Device manufacture date: unknown, because the lot number was not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during surgery that some of the healon viscoelastic passed on the side of the cannula.Reportedly, the cannula could have been disconnected but it was not damaged.No patient involvement or injury was reported.No further information was provided.The same issue was reported for 5 devices therefore 5 mdrs will be submitted.This report represents the third of the 5 reports.

• Brand Name: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS 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: 6789911
• MDR Text Key: 82728037
• Report Number: 3004750704-2017-00079
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 15050474500089
• UDI-Public: (01)15050474500089(10)UNKNOWN
• Combination Product (y/n): N
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HEALON 5
• Device Catalogue Number: 10200015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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