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

Model Number	VTICM512.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -4.50/1.0/006 (sphere/cylinder/axis) was implanted into the patient's right eye (od).The lens was exchanged for a shorter length lens due to excessive vault.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b1-adverse event or product problem: "adverse event" should be removed and corrected to state "product problem".B2-outcomes attributed to adverse event: "required intervention to prevent permanent impairment/damage" should be omitted for correction.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -4.50/1.0/006 (sphere/cylinder/axis) was intraoperatively implanted, removed, and replaced in the patient's right eye (od) on (b)(6) 2022.The lens was exchanged for a shorter length lens due to excessive vault.The problem was resolved.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 ; 8002927902
• MDR Report Key: 15180447
• Report Number: 2023826-2022-02626
• Device Sequence Number: 17401893
• Product Code: QCB
• UDI-Device Identifier: 00841542114196
• UDI-Public: 00841542114196
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM512.6
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 10/24/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/17/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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 Sex: Unknown