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

Model Number	VICM5 13.2
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	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -5.00 diopter was implanted into the patient's eye on (b)(6) 2023.The lens was removed because it was "too long." lens replaced with shorter.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Corrected data: b5-" the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -5.50 into the patient's right eye (od) on (b)(6) 2023.Reportedly "lens removed because it was too long; replaced with a 12.6 length.There was no patient injury".The lens was explanted and replaced with a shorter length." claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 16406417
• Report Number: 2023826-2023-00602
• Device Sequence Number: 15002892
• Product Code: MTA
• UDI-Device Identifier: 00841542119313
• UDI-Public: 00841542119313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2023

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: 08/31/2024
• Device Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 05/03/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/10/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female