MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON DUET; OVDS

Model Number 10-2200-10

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Corneal Edema (1791)

Event Type  Injury  

Manufacturer Narrative

Udi #: unknown, because lot # is not available.Catalog #, lot #, and expiration date: unknown, not provided.Implant date: if implanted, give date: not applicable, not an implantable product.Explant date: if explanted, give date: not applicable, not an implantable or explantable product initial reporter phone number: (b)(6).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after using the healon duet, several patients experienced corneal edema.However, it was reported that the physician was using the healon duet incorrectly where the healon was used for rhexis and the healon endocoat for bag fulfillment.The manufacturer recommends that the healon endocoat, a dispersive, should be used for the first part of the surgery to protect the endothelium and the healon is a cohesive and should be used in the second part of the surgery.No further information was provided.

Manufacturer Narrative

A batch record review or visual review of retained product was not performed as the batch number for the complaint product is unknown.The complaint device was not returned for analysis.The device complaint history review showed that there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

In the initial mdr, the incorrect model# was provided.The correct model number, 10-2200-10 has now been entered in this submission.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: HEALON DUET
• 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: 5436926
• MDR Text Key: 38204157
• Report Number: 3004750704-2016-00003
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 10-2200-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other