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

Model Number	VICM5 13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5 13.2 implantable collamer lens of -8.0 diopter into the patients right eye (od) on (b)(6) 2023.Excessive vault was observed with significant reduction of iridocorneal angles, elevated iop and angle closure after surgery.On (b)(6) 2023 the lens was exchanged for a shorter length and the problem was resolved.
Additional Manufacturer Narrative
H6- clicical code4581- significat reduction of iridocorneal angles; angle closure.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 13.2mm vicm5_ 13.2 implantable collamer lens of diopter -8.0 into the patient's right eye (od) 11/sept/2023.The patient experienced an excessive vault, significant reduction of iridocorneal angles, angle closure and elevated iop.On 22/sept/2023 the explanted.The lens was later replaced with the same model and power, shorter length and the problem was resolved.Status of the eye: "no symptoms".The reporter indicated the cause of the event is unknown.H6 - medical device problem code 1494: off-label use "under 21 yrs of age at date of implantation" and "pre-exsisting: progressive myopia" should be added.H6-health effect- impact code: "4629" should be removed and code "4627" should be added.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18176646
• Report Number: 2023826-2023-05183
• Device Sequence Number: 7625898
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: 00840311300891
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 05/31/2026
• Device Model Number: VICM5 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2026
• 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# 1637195.; FOAM TIP PLUNGER (FTP), LOT# 1577186.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male