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

Model Number	66245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint involving a potential conjunctival burn after a transcleral photocoagulation procedure using a micropulse p3 device.The doctor reported observing smoke coming from the tip of the device at the beginning of treatment.The doctor aborted the procedure after this observation.A conjunctival burn was suspected, however this was not confirmed.The ifu for the micropulse p3 probe provides instructions to the user to abort the procedure if smoke if absorbed.The user followed the instructions in this case.The most likely cause is that the laser was activated over blood or betadine during the initial treatment.These pigmented receptors can absorb energy and cause heat build-up that could cause an injury in the form of a burn.The ifu also provides instructions to the user to examine the tip of the device to make sure no blood or other contaminants are present.Per the ifu 'excessive treatment power may result in ocular surface burns or ciliary body hemorrhage.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Excessive energy may cause equatorial burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.

• 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
• MDR Report Key: 10793402
• Report Number: 2939653-2020-00006
• Device Sequence Number: 16428569
• Product Code: HQF
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66245
• Device Catalogue Number: (01) 00813125016555
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other