HEXA100 hexafocon ARecalls & reported problems
Contamac Holdings Limited · Rigid Gas Permeable Contact Lens · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00865576000287), received between Jan 18, 2024 and Jan 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
INITIAL REPORT: DECEMBER 18, 2023 FDA CONTACTED MANUFACTURER REPORT # MW5147863 RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. COMPANY IS PROCEEDING WITH AN INVESTIGATION RELATED TO THIS EVENT. FOLLOW-UP/CLOSING REPORT; (B)(6) 2024: THE PATIENT WAS SEEN FOR AN ANNUAL VISIT ON (B)(6) 2024. NO TREATMENT WAS PRESCRIBED BY THE DOCTOR IN RELATION TO THE INCIDENT. THE PATIENT DID NOT REPORT ANY INJURIES REGARDING THIS INCIDENT AT THE TIME OF HIS ANNUAL EXAM. THE PATIENT'S EYE CARE PROVIDER ORDERED A NEW PAIR OF CONTACT LENSES, DIFFERENT DESIGN/MATERIAL.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 18540590 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.