MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. WECK-CEL; PVA EYE SPEAR W/DARK BLUE HANDLE

Catalog Number	BS40400-8
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer alleged that fibers were removed from under lasik flap.( 1 of 2).

• Brand Name: WECK-CEL
• Common Device Name: PVA EYE SPEAR W/DARK BLUE HANDLE
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer Contact: aminah crawford ; 500 totten pond rd; 10 citypoint; waltham, MA 02451 ; 7815306377
• MDR Report Key: 15452792
• Report Number: 1211998-2022-00078
• Device Sequence Number: 6864657
• Product Code: OKH
• UDI-Device Identifier: 00886158014713
• UDI-Public: 00886158014713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: BS40400-8
• Device Lot Number: 21K3244
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown