Date Initiated by Firm |
September 29, 2023 |
Date Posted |
December 01, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0473-2024 |
Recall Event ID |
93312 |
PMA Number |
P030016S035 |
Product Classification |
Phakic toric intraocular lens - Product Code QCB
|
Product |
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens. |
Code Information |
T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478;
T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985;
T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704;
T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322;
T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546;
T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195
|
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 |
6 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 |
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 = QCB and Original Applicant = STAAR Surgical Company
|