MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	VICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Intraocular Pressure Increased (1937)
Date of Event	11/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.H11: manufacturer narrative: cataract and secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim#: (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an anterior subcapsular cataract (asc).In a separate visit the lens was explanted.Reportedly, "surgeon plan to do phaco and iol implantation after the eye condition is stable".Additional information provided, "during icl explantation, there were posterior synechiae and fibrin.I removed the posterior synechiae on the icl using an iris spatula, the fibrin was taken with ultrata.During installation, it looks like the visco evacuation has been confirmed to be clean." the cause of the event was reported as unknown.Cause details provided: "crystalline lens cloudiness at d+2 after icl implantation".If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: h6.Health effect - clinical code (e): 1937 should be added.H6.Health effect - impact code (f): 4644 should be added.B5- a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an anterior subcapsular cataract (asc), elevated iop and medication was prescribed.Reportedly, "after surgery the patient's condition was good so he was allowed to go home.Not long after arriving at the hotel, the patient felt nauseous and vomited.D+1 post op control, iop was high: 50mmhg, doctor gave medication for decrease the iop".In a separate visit the lens was explanted.Additional information provided, "during icl explantation, there were posterior synechiae and fibrin.I removed the posterior synechiae on the icl using an iris spatula, the fibrin was taken with ultrata.During installation, it looks like the visco evacuation has been confirmed to be clean." the cause of the event was reported as unknown.Cause details provided: "crystalline lens cloudiness at d+2 after icl implantation".Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20635237
• Report Number: 2023826-2024-05168
• Device Sequence Number: 7367529
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: (01)00840311300891(11)240420(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 04/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-1583699.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male