Intraocular lens recall: EVO+VISIAN devices may not meet specifications
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for an implantable medical device with no reported illnesses or injuries. The hazard is described as potential specification failures. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Staar Surgical Company is recalling 15 EVO+VISIAN Implantable Collamer Lens devices (REF: VTICM5_12.6), which are phakic toric intraocular lenses used in vision correction surgery.
The devices are being recalled due to a potential that they may not meet specifications. The FDA classified this as a Class II recall, indicating the devices could pose a health risk.
The recalled devices were distributed to patients across 39 U.S. states. Multiple lot numbers were affected, as documented in the recall notice.
Individuals who received one of these devices should contact their eye surgeon or ophthalmologist to verify whether their implant was affected and to discuss any necessary follow-up care.
The recalled product
- Product
- EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Hazard
- specification-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975
- T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082
- T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541
- T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771
- T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561
- T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995
- T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648
- T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982
- T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552
- T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773
- T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414
- T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808
- T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554
- T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152
- T1566889/ (01)00841542114950(11)230629(17)250531(21)T1566889
Distribution
Distributed in 38 states:
- 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
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