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U.S. Department of Health and Human Services

Class 2 Device Recall EVOVISIAN Implantable Collamer Lens

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  Class 2 Device Recall EVOVISIAN Implantable Collamer Lens see related information
Date Initiated by Firm September 29, 2023
Date Posted December 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-0467-2024
Recall Event ID 93312
PMA Number P030016 
Product Classification Lens, intraocular, phakic - Product Code MTA
Product EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Code Information UDI:(01)00841542119696(11)221031(17)240930(21)S1721962/ Serial Number: S1721962
Recalling Firm/
Manufacturer		 Staar Surgical Company
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact STAAR Customer Service
800-352-7842 Ext. 2271
Manufacturer Reason
for Recall		 Their is a potential that intraocular implant devices may not meet specifications.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action 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
Quantity in Commerce 1 unit
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MTA and Original Applicant = STAAR Surgical Company
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