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

Model Number	15522
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a patient experiencing an intraocular pressure (iop) spike followed by a swollen cornea post treatment.The doctor reported a decreased vision in the patient post-surgery.The doctor performed necessary medical intervention to bring down the iop level.Consistent follow-up regarding patient condition is being performed by an iridex representatives.No additional information regarding any underlying conditions have been provided to iridex to date.The doctor suggested that the patient could have possibly had corneal edema before surgery resulting in post-operative complications.This complaint did not involve any report of malfunction of the laser console and probe.A definitive root cause cannot be determined.Iridex will continue to follow-up regarding the patient.Engineering failure analysis was not performed because the product was not returned.
Event or Problem Description
Iridex became aware of a complaint reporting a patient experiencing an intraocular pressure (iop) spike followed by a swollen cornea post treatment.The doctor reported a decreased vision in the patient post-surgery.The doctor performed necessary medical intervention to bring down the iop level.The doctor suggested that the patient could have possibly had corneal edema before surgery resulting in post-operative complications.This complaint did not involve any report of malfunction of the laser console and probe.
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.

• 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: 13971918
• Report Number: 2939653-2022-00008
• Device Sequence Number: 20031865
• Product Code: HQF
• UDI-Device Identifier: 00813125015244
• UDI-Public: 813125015244
• 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): N
• 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): 04/24/2024

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
• 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: 03/31/2022
• 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