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

Model Number VT585U

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Implant and explant dates: if implanted or explanted, give date: not applicable as this is not an implantable device initial reporter first and last name: unknown, not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that there was no labelling on the syringe containing the healon endocoat.The syringe was reported being blank, instead of the usual printed product labelling information.There was no patient contact and no patient injury was reported.No further information was provided.

Manufacturer Narrative

Device evaluation: the syringe was not returned to the manufacturing site for investigation.A photograph of the syringe was provided to the manufacturing site for investigation.Evaluation of the product photograph confirms the complaint report.Visual inspections shows the syringe does not contain a syringe label.There is no visible label residue on the barrel of the syringe suggesting there was never a label applied to the syringe.Retain sample evaluation: visual evaluation of the product archive samples was performed for this reported lot 025994.Review confirms that all 90 retain samples contained the required syringe label.Additional product archive inspection was performed for lots manufactured in 2015 and 2016.Review confirms that all 90 retain samples for each lot contained the required syringe label.Root cause was identified as an inadequate procedure as it does not provide specific instruction on handling the label priming operation.A secondary root cause related to the potential for a label to adhere to the equipment (label applicator) was also identified.Manufacturing record review: review of the batch record found there were no non-conformances or comments applicable to this investigation.Labeled syringe units are 100% visually inspected prior to release.Based on the results of the investigation, a product deficiency has been 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.; 3515 lyman boulevard; chaska MN 55318
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5956706
• MDR Text Key: 54943397
• Report Number: 3004750704-2016-00020
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)180224(10)025994
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/24/2018
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 025994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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