STERRAD VELOCITY™ 43220Recalls & reported problems
Advanced Sterilization Products Services Inc. · STERRAD VELOCITY™ READER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705037048915), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Eye Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT A MALE HEALTH CARE WORKER (HCW) EXPERIENCED AN EYE REACTION WHILE WORKING WITH THE STERRAD VELOCITY¿ READER ON (B)(6) 2022. THE EVENT DETAILS WERE UNCLEAR; HOWEVER, THE INFORMATION AVAILABLE INDICATED THAT WHEN THE HCW WAS READING THE QR CODE ON AN AMPOULE, HE NOTICED A POOR CONNECTION WITH THE SOCKET AND THE DEVICE. WHEN HE WAS "HANDLING THE WIRE TO TRY TO CORRECT THE BAD CONTACT," HE EXPERIENCED A FLASH OF LIGHT IN HIS LEFT EYE, ALLEGED TO HAVE ORIGINATED FROM THE BARCODE SCANNER AREA, AND HE IMMEDIATELY HAD TROUBLE WITH SEEING DUE TO VISUAL ¿SMUDGES¿ AND SPOTS. THE HCW REPORTED THE SYMPTOMS TO AN OCCUPATIONAL PHYSICIAN THE FOLLOWING DAY, AND THE PHYSICIAN NOTED A CLOT IN THE CENTRAL REGION OF THE LEFT EYE. THE HCW THEN EXPERIENCED PROGRESSIVE VISUAL BLURRING DURING THE WEEK AFTER THE EVENT. ON (B)(6) 2022, HE SAW AN OPHTHALMOLOGIST AND WAS DIAGNOSED WITH MACULAR INJURY OF THE LEFT EYE. IT WAS REPORTED THE OPHTHALMOLOGIST SAID SYMPTOMS POTENTIALLY WERE RELATED TO ¿LASER EXPOSURE¿; HOWEVER, THE CAUSE COULD NOT BE ESTABLISHED WITH CERTAINTY. ON (B)(6) 2022, THE HCW UNDERWENT A NITROGEN GAS INJECTION PROCEDURE FOR THE MACULAR INJURY. LASTLY, THE HCW IS RECOV
Patient problems: Eye Injury
MAUDE report 14989837 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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