MAUDE Adverse Event Report: IRIDEX CORPORATION CYCLO G6; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	66245-1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a patient experiencing conjunctival burn during treatment with the micropulse p3 probe.The complaint also reports the presence of mucus on the probe tip during treatment.Based on the information provided by the doctor the mostly likely reason was determined to be use of the device after the device tip was contaminated.Page 1 of the micropulse p3 ifu contains instructions for inspecting and cleaning the device tip during use.Page 1 of the ifu contains 'contamination of the device tip with blood or tissue of the fiber optic by blood or tissue char can result in surface burns in the eye'.Engineering failure analysis could not be performed because the device was not returned for evaluation.This issue is not a part of an increasing trend.
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) part h: update to include that this a correction report.3) part d: updated this section with the udi number.4) part e: updates to the initial reporter section with information regarding the complainant.The following text were provided in the initial report: iridex became aware of a complaint reporting a patient experiencing conjunctival burn during treatment with the micropulse p3 probe.The complaint also reports the presence of mucus on the probe tip during treatment.Based on the information provided by the doctor the mostly likely reason was determined to be use of the device after the device tip was contaminated.Page 1 of the micropulse p3 ifu contains instructions for inspecting and cleaning the device tip during use.Page 1 of the ifu contains 'contamination of the device tip with blood or tissue of the fiber optic by blood or tissue char can result in surface burns in the eye'.Engineering failure analysis could not be performed because the device was not returned for evaluation.This issue is not a part of an increasing trend.

• Brand Name: CYCLO G6
• 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: 12100888
• Report Number: 2939653-2021-00015
• Device Sequence Number: 17208173
• Product Code: HQF
• UDI-Device Identifier: 00813125016555
• UDI-Public: 00813125016555
• 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): 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: 66245-1
• 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: 07/01/2021
• 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