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

Model Number	15980
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient experiencing scleral perforation during treatment using a g-probe and cyclo g6 laser system based on the information provided, it appears the treatment was performed within specifications.A definitive root cause could not be determined.Follow up emails with the clinic has confirmed that no laser malfunction was observed during the procedure.The treating physician did not observe any contamination at the tip of the device and confirmed the absence of pigmentation in the eye prior to the procedure.Engineering failure analysis has not yet been performed because the returned probe has not been received.Failure analysis will be completed once the probe is received.If new information becomes available, this record will be amended.The results of post market data review indicate that this failure mode is not occurring with greater severity or frequency based on the number of events reported evaluated against the number of cases performed.
Additional Manufacturer Narrative
This follow-up report is provided to update the following: 1)part b: b5 -product problem section was updated.2) report c: is this a combination product - no.3) report d: updates to section d8, d9, d4.4) part h: update to include that this a correction and additional information report 5) part d: updated this section with the udi number.6) part e: updates to the initial reporter section with information regarding the complainant.Note: patient information was not provided, therefore part a is not filled out.
Event or Problem Description
Iridex became aware of a patient experiencing scleral perforation during treatment using a g-probe and cyclo g6 laser system based on the information provided, it appears the treatment was performed within specifications.Follow up emails with the clinic has confirmed that no laser malfunction was observed during the procedure.The treating physician did not observe any contamination at the tip of the device and confirmed the absence of pigmentation in the eye prior to the procedure.

• 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
• Manufacturer Contact: madhumita srikanth ; 1212 terra bella ave; mountain view, CA 94043-9149 ; 6502189149
• MDR Report Key: 14739021
• Report Number: 2939653-2022-00017
• Device Sequence Number: 5936306
• Product Code: HQF
• UDI-Device Identifier: 00851089000234
• UDI-Public: 851089000234
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• 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): 04/25/2024

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: 06/17/2022
• Supplement Report FDA Received Date: 05/03/2024
• 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