MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	15522
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure and that the patient experienced a conjunctival burn.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.A conclusive root cause for this event was not determined.Engineering failure analysis could not be performed because the device was not returned for evaluation.Based on the information provided by the treating physician, it is possible that the substitution of an alternative anesthetic lubricating gel may have contributed to this event.The physician noted that she used more gel that usual and suspected this may have played a role.The manufacturing device history records were reviewed, and no anomalies or issues were identified.The results of post market data review suggest 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,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: part a has been updated to reflect patient age, race and sex.
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure and that the patient experienced a conjunctival burn.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.Information provided by the treating physician indicates that the that the substitution of an alternative anesthetic lubricating gel may have contributed to this event.Although the physician used a gel that is not indicated for ophthalmic use, iridex is not aware of any chemical properties of the gel that would lead to burn.The physician replaced the probe, changed the lubricating gel and completed the treatment successfully with no further complications.

• Brand Name: MICROPULSE P3
• 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: 14277527
• Report Number: 2939653-2022-00012
• Device Sequence Number: 11972026
• Product Code: HQF
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• 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: 15522
• 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: 05/04/2022
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American