MAUDE Adverse Event Report: AVID MEDICAL INC. , A MEDICAL ACTION IND. COMPANY 305 AVMID CATARACT SURGERY KITS; EYE TRAY

Catalog Number VAOR023-01

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/03/2019

Event Type  Injury  

Event Description

After intensive investigation under the microscope, the (b)(6) medical center found the avmid packs / kits products have been the source of fibers that were discovered in the eyes of several pts on day 1 and 1 week.Providers notes: fibers on the field within this package are seen on the sterile blue drape (source) loose and freely attaches to anything that lands on the field.Paper towels (possible source) - when rubbed or touch by gloves, lets out fibers onto the gloves 4x4, qtips cta - (least likely source, as these are difficult to pull off and rub off) - not free, weaved tightly.Blue basins are massively infected by particles only seen under microscope and with perfect lighting using a bubble of bss fluid to see it floating i the droplet.Otherwise not able to see with naked eye or in the surgical eye at time of surgery with brown or blue iris background.Black dust particles, red fibers/lint, green fibers/lint, lots of white dust / debris.Syringes (open, are not individually packed) found in the basins have fibers inside of them, inside the syringe barrel.This was compared to syringes that were individually packaged bd brand name not from the avmed pack, which were crystal clear inside.Fda safety report id# (b)(4).

• Brand Name: AVMID CATARACT SURGERY KITS
• Type of Device: EYE TRAY
• Manufacturer (Section D): AVID MEDICAL INC. , A MEDICAL ACTION IND. COMPANY 305 ; toana WV 23168
• MDR Report Key: 8772538
• MDR Text Key: 150822388
• Report Number: MW5087952
• Device Sequence Number: 4
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/03/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VAOR023-01
• Device Lot Number: 13344
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention