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

Model Number	VTICM5_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	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -11.0/1.5/047 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The patient experienced low vaulting.On (b)(6) 2023 the lens was explanted.This resolved the problem.The cause of the event was reported as "other" and noted "longer length needed"; the device did not fail to perform as intended.It was additionally noted "explanted icl until longer length received".
Additional Manufacturer Narrative
Type of investigation: 4110 lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a specimen cup with moisture.Visual inspection found optic torn.Dimensional inspection found the lens to be within specifications.Additional information: b5- the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -11.00/+1.50/047 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2023.The patient experienced a low vault.Reportedly "he will be implanting a larger icl." on (b)(6) 2023 the lens was explanted.A replacement lens was implanted and the problem was resolved.Reportedly "the exchange went well and all is within normal limits".The reporter indicated the cause of the event as other and the device did not fail to perform as intended.Cause details- "longer length needed".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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16413690
• Report Number: 2023826-2023-00684
• Device Sequence Number: 3504362
• Product Code: QCB
• UDI-Device Identifier: 00841542116725
• UDI-Public: 00841542116725
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: VTICM5_13.2
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female