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

Model Number	VTICMO 13.2
Medical Device Problem Codes	Optical Problem (3001); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Glaucoma (1875); Intraocular Pressure Increased (1937); Blurred Vision (2137); Halo (2227); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -14.50/1.0/090 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to eye pain; angle closure with elevated iop and glare/haloes."pain in left side after implantation.Pushing forward on iris.Glaucoma suspect possible; photosensitivity.Pigmentation." cause reported as unknown.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vticmo 13.2 implantable collamer lens of -14.50/1.0/090 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6)2022.On (b)(6) 2022, the lens was explanted due elevated iop; pigment dispersion; blurred vision; angle closure with elevated iop.The problem was resolved.Status of eye is "mgd." cause is reported as patient related factor; device did not fail to perform as intended.H6-clinical code 4581- pigment dispersion.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15434626
• Report Number: 2023826-2022-03079
• Device Sequence Number: 14970173
• Product Code: QCB
• UDI-Device Identifier: 00841542120852
• UDI-Public: 00841542120852
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICMO 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female