MAUDE Adverse Event Report: ALMA LASERS LTD OPUS WITH COLIBRI TIP AND PLASMA

Catalog Number	AASP12091701BA0001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Scar Tissue (2060); Hyperpigmentation (4837)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported about a hyperpigmentation and a scar around both eyes following the opus colibri treatment.
Additional Manufacturer Narrative
Hyperpigmentation , scarring and pinpoint depression around both eyes following the opus colibri treatment ,that may be permanent in some areas.
Additional Manufacturer Narrative
Hyperpigmentation, scarring and pinpoint depression around both eyes following the opus colibri treatment, that may be permanent in some areas.Udi related data quality updates.This supplemental report represents a correction to a previously submitted mdr.
Event or Problem Description
It was reported about a hyperpigmentation and a scar around both eyes following the opus colibri treatment.

• Brand Name: OPUS WITH COLIBRI TIP AND PLASMA
• Common Device Name: OPUS
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS, LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 19157365
• Report Number: 3004167969-2024-00007
• Device Sequence Number: 7548457
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)230905
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2024

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
• Device Catalogue Number: AASP12091701BA0001
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 12/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female