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

Model Number	15522
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting that a patient experienced a scleral burn during treatment with a micropulse p3 probe.The complaint also reports the presence of blood 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 with blood.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'.The complainant reported that no malfunction of the laser console and delivery device was observed.Engineering failure analysis was not performed as the micropulse p3 probe was not returned to iridex by the customer.
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 complaint reporting that a patient experienced a scleral burn during treatment with a micropulse p3 probe.It was reported that "the surgical field was rather bloody due to bleeding from vascularized limbal epithelial surface, with blood seeping into the 1mm air space of the laser probe, resulting in the charring of the laser probe and minute areas of the patient's superior conjunctiva." laser treatment was stopped immediately, blood was cleared from the surgical field, and treatment was completed with a new probe.Based on the information provided by the complainant, the most likely cause of the burn was determined to be use of the device after the device tip was contaminated with blood.The micropulse p3 ifu contains instructions for inspecting and cleaning the device tip during use, and the ifu contains the warning that "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." the complainant reported that no malfunction of the laser console and delivery device was observed.No other information was provided regarding the patient's post-procedural status.

• Brand Name: CUST-CYLCO-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: 13177555
• Report Number: 2939653-2022-00001
• Device Sequence Number: 11902803
• Product Code: HQF
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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
• Device Catalogue Number: (01) 00813125016555
• Device Lot Number: 800336
• Was Device Available for Evaluation?: No
• 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: 01/06/2022
• 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