MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	15980
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a scleral burn during treatment with a g-probe.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
Event or Problem Description
Part a is not filled out as patient identifier details were not provide to iridex.This report has been created to make corrections to the previous report.The changes include: 1) report c: is this a combination product - no.2) report d: updates to section d8, d9.3) part h: update to include that this a correction report.4) part d: updated this section with the udi number.5) part e: updates to the initial reporter section with infromation regarding the complainant.The following text were provided in the initial report: iridex became aware of a complaint reporting a scleral burn during treatment with a g-probe.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.

• Brand Name: G-PROBE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• MDR Report Key: 17385523
• Report Number: 2939653-2023-00014
• Device Sequence Number: 20386178
• Product Code: HQF
• UDI-Device Identifier: 00813125016036
• UDI-Public: 00813125016036
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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 Number: 15980
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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 Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown