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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11- 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 medical professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced blurred vision.In a separate visit the lens was rotated/ repositioned.Medication was prescribed.At a later date the lens was exchanged.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: d4.- model#: "vticm5_ 12.6" should be added.D4.- serial#: "(b)(6)" should be added.D4.- expiration date: "12/31/2026" should be added.D4.- primary uniquq identifier (udi)#: "(b)(4)" should be added.H4.- device manufacture date: "01/23/2024" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- a medical professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced blurred vision.In a separate visit the lens was rotated/ repositioned.At a later date the lens was exchanged.H6- health effect - impact code (f): '4644' should be removed.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 21260159
• Report Number: 2023826-2025-00143
• Device Sequence Number: 8075186
• Product Code: QCB
• UDI-Device Identifier: 00840311307739
• UDI-Public: (01)00840311307739(11)240123(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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: VTICM5_12.6
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/29/2025; 03/29/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/29/2025
• Date Device Manufactured: 01/23/2024
• 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#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female