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

Model Number	VTICMO12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 12.6mm vticmo 12.6 implantable collamer lens of -17.0/2.5/086 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2022 as an exchange lens.It is reported that "the icl has low vault with significant inferior decentration and ccw rotation.Despite replacing icl with one step larger sized icl the vault remains shallow and inferior decentration supports undersizing of replacement icl despite increasing size one step." the lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.See mfr# 2023826-2022-04429 for initial lens.
Additional Manufacturer Narrative
Clinical code: 4581: significant inferior decentration.Investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5: received information that this exchange lens did resolve the issue of low vault.This claim is not a complaint due to no product deficiency against the lens.Please disregard the initial mdr.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: 16019193
• Report Number: 2023826-2022-04657
• Device Sequence Number: 12233206
• Product Code: QCB
• UDI-Device Identifier: 00841542120678
• UDI-Public: 00841542120678
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICMO12.6
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Patient Age: 39 YR
• Patient Sex: Female