MAUDE Adverse Event Report: IRIDEX CORPORATION ASSEMBLY, TOP 5mm LS SLA, HS; SLIT LAMP ADAPTER

Model Number	13880-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Iridex received a report indicating that the slitlamp adapter (sla) treatment beam and aiming beam were superimposed.This could result in treatment of an unintended area.

• Brand Name: ASSEMBLY, TOP 5mm LS SLA, HS
• Common Device Name: SLIT LAMP ADAPTER
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• MDR Report Key: 8533616
• Report Number: 2939653-2019-00005
• Device Sequence Number: 13821573
• Product Code: GEX
• UDI-Device Identifier: 00813125011345
• UDI-Public: (01)00813125011345(11)190206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K912918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 13880-01
• Device Catalogue Number: 13880-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/19/2019
• 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