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

Model Number VT585U

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If implanted; give date: not applicable.If explanted; give date: not applicable.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a healon endocoat syringe popped off and patient lost zonules in the left eye.Reportedly, syringe guard was not used as instructed and the doctor had to use a capsular tension ring.No further information was provided.

Manufacturer Narrative

Device evaluation: complaint device was not returned for evaluation as it was reported as discarded by the customer.The manufacturing and receiving inspection records were reviewed.There were no deviations or comments regarding cannula attachment.Final product testing requires the connection of the cannula to the syringe for expelling product used in testing activities.The investigation shows that the (b)(4) syringes and cannulas used were found to be acceptable and that the final product lot met the product specifications.  a review of the complaints did not indicate any trend.  based on the investigation results, no root cause related to the manufacturing process could be identified.  all pertinent information available to abbott medical optics has been submitted.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; amo uppsala; rapsgatan; uppsala 751 82; SE 751 82
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5540003
• MDR Text Key: 41611618
• Report Number: 3004750704-2016-00005
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/29/2017
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 025834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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): Required Intervention
• Patient Age: 89 YR