Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand

FDA Recall Z-1435-06 · Posted 2006-08-23

Recalling FirmMicrovision Medical Holding B.V.
Recall StatusTerminated
Product CodeFSO
Date Initiated2006-07-21
Date Terminated2006-11-15
Product Quantity540 caps

Reason for Recall

Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier

Firm Action

The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑