MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3 DEVICE; MP3 PROBE

Model Number	15522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Eye Injury (1845); Eye Burn (2523)
Date of Event	12/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to iridex that a patient experienced a conjunctival burn during treatment with the micropulse p3 probe delivery device.The complainant also complained that the probe turned black.No further information regarding the reported adverse event was given.Iridex is currently investigating the complaint and attempts to contact the complainant has been made to gather more information.
Additional Manufacturer Narrative
810 nm ophthalmic laser systems are intended to deliver thermal (laser) energy to deliver an insult (burn) to the ciliary body.Conjunctival burns are a known and predicted complication associated with the use of any 810nm ophthalmic laser system (console and delivery device) when used to deliver transscleral treatment.Conjunctival burns are typically superficial and typically pose no long-term threat to the patient (i.E., no adverse effect on patient disease state, no requirement for additional future care).Typically, these burns resolve within 24-48 hours post op without additional intervention.The result of these burns requires no post-operative management nor change to the post-operative medication regimen within the normal post-operative appointment schedule.The most likely cause of the reported adverse event is suspected to be contamination (e.G., blood, tissue or betadine) on the probe tip when the laser was activated.The micropulse p3 delivery device ifu warns that contamination at tip may cause ophthalmic burns: "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".The micropulse p3 delivery device ifu warns that use in pigmented eyes may cause ophthalmic burns: "heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation." the user reported that there was pigmentation present in the surgical field.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MP3 PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view, CA 94043-9149
• MDR Report Key: 19548125
• Report Number: 2939653-2024-00006
• Device Sequence Number: 6711887
• Product Code: GEX
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2023
• Initial Report FDA Received Date: 06/17/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown