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

Model Number	VICM5 13.7
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -13.00 diopter was implanted into the patient's right eye (od) on an unknown date.Excessive vault was reported and blurred vision.The lens remains implanted.Cause reported as device.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - it was later reported that on (b)(6) 2023 the lens was repositioned and this resolved the problem.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: previous supplemental mdr #1 is not applicable.Below is the correct information.B1: adverse event.B2: required intervention to prevent permanent impairment/damage.B5: the reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -13.00 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was exchanged for a shorter length lens due to excessive vault and blurred vision.The replacement lens resolved the problem.D6a-(b)(6) 2023.D6b-(b)(6) 2023.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263039702
• MDR Report Key: 17891552
• Report Number: 2023826-2023-04271
• Device Sequence Number: 7289420
• Product Code: MTA
• UDI-Device Identifier: 00840311301324
• UDI-Public: 00840311301324
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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: 03/31/2026
• Device Model Number: VICM5 13.7
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 02/21/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/23/2023; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: 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: 30 YR
• Patient Sex: Female