EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.

FDA device recall Z-0470-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

Staar Surgical Company

Reason for recall

Their is a potential that intraocular implant devices may not meet specifications.

Action taken

On October 25, 2023, Staar Surgical issued a "Urgent: Medical Device Voluntary Recall" notification to affected consignees. Staar Surgical ask consignees to take the following actions: 1. Review your current inventory of STAAR EVO/EVO+ devices. 2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the product. 3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession. 4. Fax the form within 5 days upon receipt of this notification to: 1-800-952-4923 or email a pdf copy of the form to: atramontana@staar.com. 5. Return the EVO/EVO+ device(s) with the Medical Device Recall Return Response form to STAAR Surgical using the prepaid postage to the address identified in the attached Medical Device Recall Return Response form. 6. Apply the enclosed sticker/label "Attn: Recall Coordinator" to the outside of each ICL box being returned to STAAR Surgical. 7. Affected product and distribution information specific to your facility is contained in the Medical Device Recall Return Response Form

Root cause

Software design (manufacturing process)

Status

Open, Classified

Product code

QCB

Quantity affected

3 units

Distribution

US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None

Date initiated

2023-09-29

Date posted

2023-12-01

Location

Monrovia, CA