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

Model Number	VTICMO 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a toric implantable collamer lens into the patient's right eye (od).The patient experienced residual refractive error.Reportedly "the post op refraction (-5) is quite a bit off from the predicted spherical equivalent (-2)." the lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additonal data: b5- the reporter indicated that the surgeon implanted a 12.6mm vticmo 12.6 implantable collamer lens of diopter - 17.00/2.0/070 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2024.The patient experienced refractive surprise.Reportedly "the post op refraction (-5) is quite a bit off from the predicted spherical equivalent (-2)." the lens remains implanted.Status of the eye: "likely will perform laser vision correction for residual refractive error.Pending".The cause of the event is unknown.Cause details provided: "could have been inaccurate pre-operative refraction".If additional information is received a supplemental medwatch report will be submitted.H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC LNTRAOCULAR 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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19455498
• Report Number: 2023826-2024-02531
• Device Sequence Number: 17807691
• Product Code: MTA
• UDI-Device Identifier: 00841542120661
• UDI-Public: 00841542120661
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 04/30/2024
• Device Model Number: VTICMO 12.6
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 05/27/2022
• 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: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: LIOLL-24, LOT# UNK.; MSI-PF, LOT# UNK.
• Patient Age: 39 YR
• Patient Sex: Female