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

Model Number	VICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.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 facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.The lens was explanted.No further information is available at this time.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H3-device evaluation: lens returned in a microcentrifuge vial in liquid with residue/debris on product.Visual inspection found no visible damage to the lens.Dimensional inspection and functional inspection found the lens to be within specifications.Claim# (b)(4).
Additional Manufacturer Narrative
B5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.On a separate visit the lens was exchanged and the problem was resolved.Cause reported as user error.D6b- (b)(6) 2024.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.On a second visit the lens was explanted.On a third visit a replacement lens of the same model and size but different diopter was implanted.The replacement lens resolved the problem.Cause reported as user error.D6b- (b)(6) 2024.Corrected data; d4: primary unique device identifier (udi) #: (b)(4), "udi related data quality updates only." 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20041222
• Report Number: 2023826-2024-03538
• Device Sequence Number: 18131447
• Product Code: QCB
• UDI-Device Identifier: 00840311300969
• UDI-Public: (01)00840311300969(11)240122(17)261231(21)S2308318
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2024

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: VICM5 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 12/16/2024; 12/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/10/2024; 12/17/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female