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

Model Number	VTICM512.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: 1 similar complaint: claim# (b)(4) (fellow eye).Claim# (b)(4).
Event or Problem Description
The reporter indicated that 12.6mm vticm512.6 implantable collamer lens of a -7.0/1.0/106 (sphere/cylinder/axis) was implanted into the patient's left eye (os).Low vault and refractive miss were reported.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -7.00/1.0/106 (sphere/cylinder/axis) into the left eye (os) on (b)(6) 2023.The patient experienced a low vault and refractive miss.On (b)(6) 2023 the lens was explanted and replaced with a longer length.D6a: "on (b)(6) 2023" should be added.D6b: "on (b)(6) 2023" should be added.H6: health effect- impact code: "2199" should be removed and code "4627" should be added.H6: medical device problem code: "3189" should be removed and "2993" and "1401" should be added.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5-the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -7.00/1.0/106 (sphere/cylinder/axis) into the left eye (os) on (b)(6) 2023.The patient experienced a low vault and refractive surprise.On (b)(6) 2023 the lens was exchanged with a longer length.H6-health effect- impact code: "4627" should be removed and code "4629" should be added.Device evaluation: h3 -type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found haptic torn.Dimensional and functional inspection found the lens to be within specifications.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 muniz ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18275560
• Report Number: 2023826-2023-05475
• Device Sequence Number: 7152653
• Product Code: QCB
• UDI-Device Identifier: 00841542114547
• UDI-Public: 00841542114547
• 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
• 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,Followup
• Report Date (Section B): 11/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: VTICM512.6
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 06/12/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/21/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown