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

Model Number VICM5 12.6

Device Problems Off-Label Use (1494); Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

H6-clinical code 4581: patient dissatisfaction with visual acuity.(b)(4).

Event Description

The reporter indicated that a 12.6mm vicm5 12.6 implantable collamer lens of -1.50 diopter was implanted into the patients left eye (os) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to patient dissatisfaction-visual acuity.The problem was resolved.

Manufacturer Narrative

H3-device evaluation: lens returned in a microcentrifuge vial with residue/debris on product.Visual inspection found no visible damage to lens and residue throughout the lens.Claim# (b)(4).

Manufacturer Narrative

H6: medical device code: 1494 off-label: safety and effectiveness of the lens has not been established in patients with: unstable refractive error in either eye.Safety and effectiveness of the lens has not been established in patients with: history of previous ocular surgery including refractive corneal surgery.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: 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: 18240577
• MDR Text Key: 329400419
• Report Number: 2023826-2023-05229
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Model Number: VICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 02/16/2024
• Supplement Dates FDA Received: 02/06/2024; 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female