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

Model Number	VTICM512.1
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm vticm512.1 implantable collamer lens of -10.0/3.0/001 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2023.On (b)(6) 2023 the lens was exchanged for a same length, spherical lens, implanted vertically due to low vault with rotation.The exchange resolved the problem.Reportedly, "1) initial lens: implanted vertically, 2) exchange lens: implanted horizontally, 3) lri performed for astimatism.".
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6- medical device problem code: "2923" 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 ; 6263037902
• MDR Report Key: 16905660
• Report Number: 2023826-2023-01719
• Device Sequence Number: 12152921
• Product Code: QCB
• UDI-Device Identifier: 00840311305582
• UDI-Public: 00840311305582
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 06/23/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/23/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female