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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
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; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF Back to Search Results
Model Number 66245
Health Effect - Clinical Code Blurred Vision (2137)
Date of Event 09/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a case of mydriasis followed by blurry vision post treatment using a cyclo g6 console with a micropulse p3 probe.Mydriasis is a condition where the pupil of the eye is fixed and dilated.The doctor was a new iridex device user.The procedure was intended by an iridex representative who confirmed that treatment settings were within specification and the doctor used a good technique.This complaint did not involve any report of malfunction of the laser console and probe.A definitive root cause cannot be determined.
 
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Common Device Name
LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
MDR Report Key12677653
Report Number2939653-2021-00019
Device Sequence Number14477884
Product Code HQF
UDI-Device Identifier00813125016555
UDI-Public0100813125016555
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number66245
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/21/2021
Was Device Evaluated by Manufacturer? (Y/N) No
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 Number1
Outcome Attributed to Adverse Event Other;
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