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

Model Number	VICM5_13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	Halo (2227)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -7.50 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.It was reported that the patient has low vaulting with rotation, the lens had tore during injection/delivery into the eye, and the patient has glare/haloes.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial in liquid.Visual inspection found the lens haptic broken.Dimensional inspection was unable to be performed due to significant lens damage.Claim#: (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -7.50 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.It was reported that the patient has low vaulting with rotation, the lens had tore during injection/delivery into the eye, and the patient has glare/haloes and the lens was decentered.On (b)(6) 2023 the lens was exchanged with a same length/power lens and this resolved the problem.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
• MDR Report Key: 18375453
• Report Number: 2023826-2023-05764
• Device Sequence Number: 7710422
• Product Code: MTA
• UDI-Device Identifier: 00840311300884
• UDI-Public: 00840311300884
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 11/27/2023

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: 02/28/2026
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: Not provided; 04/23/2024; 06/05/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/19/2024; 04/23/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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#-1626240.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1648271.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female