MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, LTD BVI LASIK FLAP SEPARATOR/ELEVATOR (SEIBEL)

Model Number	MMSU1172S
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following investigation conclusions.
Event or Problem Description
A complaint was received for product mmsu1172s - lasik flap separator (seibel), in which a surgeon reported observing fine metallic particles beneath the corneal flap on postoperative day one.The particles were not removed, and no adverse patient effects have been reported to date.The physician requested instruments from a different lot, noting that similar issues have previously occurred with older reusable instruments.According to a clinical expert, the presence of interface debris (metal or plastic particles), if not removed, poses a potential risk of developing diffuse lamellar keratitis (dlk), also known as "sands of the sahara" syndrome an inflammatory condition that can result in serious injury, including corneal haze and vision loss.The malfunction was identified postoperatively but did not result in any adverse health effects and the physician decided that it doesn't require medical intervention.Although recurrence does not guarantee harm, it carries the potential for serious injury, particularly if toxic, allergic, or inflammatory responses are triggered.
Additional Manufacturer Narrative
A complaint was received for product: mmsu1172s - lasik flap separator (seibel), where the surgeon reported observing fine metallic particles under the corneal flap on postoperative day 1 in multiple lasik patients.The physician decided not to remove the particles, and no patient impact has been reported to date.Given the confirmed presence of metallic particles in the eye, the potential for long-term complications, and the clinical literature linking such debris to serious inflammatory responses, we considered this event as reportable.The bvi quality assurance department conducted a full investigation in line with internal procedures.This included a review of the device history record (dhr) and current process controls.All manufacturing steps were found to be properly documented, with no nonconformities identified for the affected product.Following a detailed investigation, it has been determined that a definitive root cause cannot be established due to the absence of physical product samples or photographic evidence to support the complaint.While it is possible that the presence of metal shavings may have originated during the manufacturing process at the sub-contract facility, this cannot be confirmed without direct evidence.The sub-contractor's manufacturing and inspection processes - designed to detect and eliminate foreign material - remain in place, and additional inspections are carried out at the bvi bidford plant prior to final packaging.Given the lack of supporting evidence, no corrective or preventive action (capa) will be taken at this time.However, the issue will be monitored for recurrence, and any similar future complaints will be reviewed collectively to determine if further investigation or action is warranted.

• Brand Name: BVI LASIK FLAP SEPARATOR/ELEVATOR (SEIBEL)
• Common Device Name: BVI LASIK FLAP SEPARATOR/ELEVATOR (SEIBEL)
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, LTD; waterloo industrial estate; bidford-on-avon 8a; warwickshire B50 4 JH; UK B50 4JH
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, LTD; waterloo industrial estate; bidford-on-avon 8a; warwickshire B50 4 JH; UK B50 4JH
• Manufacturer Contact: agnieszka drzewiecka ; waterloo industrial estate; bidford-on-avon 8a; warwickshire B50 4-JH ; UK B50 4JH
• MDR Report Key: 22541762
• Report Number: 3002808441-2025-00007
• Device Sequence Number: 6975192
• Product Code: MDM
• UDI-Device Identifier: 05055186206000
• UDI-Public: (01)05055186206000(17)290429(10)000003534260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: MMSU1172S
• Device Catalogue Number: N/A
• Device Lot Number: 000003534260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown