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

Model Number VT585U

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Hemorrhage/Bleeding (1888); Hyphema (1911); No Code Available (3191)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.If implanted; give date: na (not applicable).If explanted; give date: na (not applicable).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during use of the healon endocoat, the fulcrum (finger rest) came loose and resulted in a patient injury.The iris was pierced and the capsular bag was broken.Postop, the patients anterior chamber was filled with blood.The white fulcrum piece that came loose was examined, and it was not snapped into place which resulted in patient injury.Upon examination, the piece was able to be snapped back onto the viscoelastic and was not damaged.The preloaded tecnis lens, model pcb00 was successfully placed in the capsular bag.Further information provided states the patient has a small iridodialysis, a vitreous hemorrhage, and a hyphema.The doctor stated that he never looks at which way the fulcrum is placed on the viscoelastic device.The assistant puts it in my hand while i am looking through the scope.No further information provided.

Manufacturer Narrative

Corrected data: the initial mdr notes serial number (b)(4).This is actually a lot number.The lot number has been entered into the correct box.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for evaluation.Visual inspection could not be performed.Batch record review determined components were inspected, evaluated, and accepted per (b)(4) specification.The root cause of this incident does not appear to be related to the manufacturing process.Record review determined there were no deviations or comments regarding finger grip detachment.The root cause of this complaint is not likely related to the manufacturing process.Record review determined components were inspected, evaluated, and accepted per (b)(4) specifications.The investigation indicates that the lot meets the product specification.(b)(4) will continue monitoring for any trend related to this type of complaint based on the investigation results there is no indication of a product quality deficiency.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 8 2; SE 751 82
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5542864
• MDR Text Key: 41715328
• Report Number: 3004750704-2016-00006
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 025682
• 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: 10/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0530-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention