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

Model Number	VTCM5_13.2
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.50/1.0/071 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The patient experienced lens rotation with blurry vision.Lens remains implanted.
Additional Manufacturer Narrative
H6: type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: 433701.
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with moisture.Visual inspection found optic/haptic torn.Due to the damage of the lens, dimensional inspection will not be able to be performed.Additonal information: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -7.50/1.0/071 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced blurry vision and lens rotation not associated with low vault.Reportedly "blurry vision, icl rotated to axis of 168, post-op refraction -0.50/1.5/87".The lens was explanted.The reporter indicated the cause of the event is unknown.H6- health effect- impact code (f): "2199" should be removed and "4629" should be added.H6- medical device problem code (a): "2993" should be added.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: 18727073
• Report Number: 2023826-2024-00713
• Device Sequence Number: 6292355
• Product Code: QCB
• UDI-Device Identifier: 00841542116220
• UDI-Public: 00841542116220
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: VTCM5_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: 01/29/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male