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

Model Number	VTICM512.1
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that 12.1mm vticm512.1 implantable collamer lens of a -8.5/4.0/076 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2023.Lens rotaton was observed.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected information: b5- the reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1 implantable collamer lens of diopter -8.50/4.0/076 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2023.The patient experienced lens rotation and loss of visual acuity.Reportedly "os has a rotation of the -8.5/4.0/076 evo (b)(6) to 160 degrees when it was placed at 179; the patient's vision dropped from 20/25 at week 1 to 20/60 today.This was the recommended 12.1mm size (pentacam 11.1mm/iol master 700 was 11.4mm; true acd 3.03mm) but the vault is about 50% corneal thickness.This may have led to the rotation".The lens was explanted.H6- health effect - impact code: "2137" should be added.H6- health effect - impact code: "2199" should be removed and "4627" should be added.H6- medical device problem code: "3189" should be removed and "2993" be added.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found optic and haptic torn.Due to lens damage a dimensional inspection could not be performed.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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18407299
• Report Number: 2023826-2023-05801
• Device Sequence Number: 2761455
• Product Code: QCB
• UDI-Device Identifier: 00841542113205
• UDI-Public: 00841542113205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/19/2023

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: 05/31/2025
• Device Model Number: VTICM512.1
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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 Age: 35 YR
• Patient Sex: Unknown