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

Model Number	VT585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: if implanted; give date: na/not applicable; healon endocoat is a non-implantable cohesive device.Explant date: if explanted; give date: na/not applicable.(b)(4).Device evaluation: the device was not returned at the manufacturing site for evaluation.Manufacturing records review: the manufacturing records were reviewed.During the manufacturing record review of the production order for this lot number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.During manufacturing process, all units are inspected for proper assembly and damage after syringe assembly.A review of the complaints was done and no trend was indicated.Based on review, this complaint is not likely related to the manufacturing process.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that part of the healon endocoat syringe dislodged.When doctor was injecting healon endocoat inside the eye, the removable white fulcrum piece came loose resulting in the sudden and forceful movement of the device towards the eye while the cannula was already inserted inside the eye.Nothing on the device broke loose other than the white fulcrum piece.When withdrawn, it tore anterior capsule causing doctor to have to change his lens selection to a 3 piece lens.The doctor believes that the removable white fulcrum piece was indeed snapped firmly in place upon use in this case and came dislodged only during use by the doctor while inside the eye.Reportedly, there was no visible damage or cracks on the white finger grip; orientation of the finger grip in relation to the injection hand while in use is unknown.Incision enlargement was required.Patient is doing well.No further information was provided.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6119287
• Report Number: 3004750704-2016-00030
• Device Sequence Number: 52304
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)161031(10)025682
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: VT585
• Device Catalogue Number: VT585U
• Device Lot Number: 025682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention