EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Recall
- Recall Number
- Z-0464-2024
- Event Number
- 93312
- Firm
- Staar Surgical Company
- FEI Number
- 2023826
- Product Code
- MTA
- Status
- Open, Classified
- Root Cause
- Software design (manufacturing process)
- Initiated
- September 29, 2023
- Posted
- December 1, 2023
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846
Description
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
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: [email protected]. 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
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20 units