EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Reported: December 13, 2023 Initiated: September 29, 2023 #Z-0466-2024
Product Description
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Reason for Recall
Their is a potential that intraocular implant devices may not meet specifications.
Details
- Recalling Firm
- Staar Surgical Company
- Units Affected
- 51 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
- Location
- Monrovia, CA
Frequently Asked Questions
What product was recalled? ▼
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.. Recalled by Staar Surgical Company. Units affected: 51 units.
Why was this product recalled? ▼
Their is a potential that intraocular implant devices may not meet specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0466-2024.
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