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

Model Number	VTICM5 12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: investigation type: lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -13.5/1.5/090 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2022 as an exchange lens.Icl has persistently low vault ~10% centrally which decreases towards midperiphery.The lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.Mfr# 2023826-2022-04428 for initial lens.
Additional Manufacturer Narrative
Additionalinformation: 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: 16018260
• Report Number: 2023826-2022-04656
• Device Sequence Number: 12432046
• Product Code: QCB
• UDI-Device Identifier: 00841542115469
• UDI-Public: 00841542115469
• 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: 09/30/2022
• Device Model Number: VTICM5 12.6
• 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: 10/18/2022
• 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