MAUDE Adverse Event Report: BEAVER VISITEC INTERNATIONAL LIMITED MALOSA; MICS CAPSULORHEXIS - CURVED/SHARP

Catalog Number MMSU1567CS

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Customer alleged that there was a tearing of the corneal incision and that metal flake deposits were found in the incision.

• Brand Name: MALOSA
• Type of Device: MICS CAPSULORHEXIS - CURVED/SHARP
• Manufacturer (Section D): BEAVER VISITEC INTERNATIONAL LIMITED; waterloo industrial estate; bidford-on-avon, B50 4 JH,; UK B50 4JH,
• Manufacturer (Section G): BEAVER VISITEC INTERNATIONAL LIMITED; waterloo industrial estate; bidford-on-avon, B50 4 JH,; UK B50 4JH,
• Manufacturer Contact: aminah crawford ; 500 totten pond rd; 10 citypoint; waltham, MA 02451
• MDR Report Key: 17275039
• MDR Text Key: 318594694
• Report Number: 3002808441-2023-00010
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

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: MMSU1567CS
• Device Lot Number: 3432004
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1