Staar Surgical AG Recalls EVO+ Visian Toric Implantable Collamer Lenses Due to Labeling Error
Staar Surgical AG has issued a recall for specific EVO+ Visian Toric Implantable Collamer Lenses (TICL) that were mislabeled with the incorrect length, posing risks of ocular complications.
What Happened
Staar Surgical AG has initiated a voluntary recall of seven units of its EVO+ Visian Toric Implantable Collamer Lens (TICL). The devices, intended for the correction or reduction of myopia in phakic eyes with astigmatism, were incorrectly labeled as having a length of 12.1 mm when they are actually 12.6 mm in length. This discrepancy creates a potential for “excessive vault” once the lens is implanted.
Which Products Are Affected
The recall affects the following specific medical device:
- Product Name: EVO+ Visian Toric Implantable Collamer Lens (TICL)
- Model Number: VTICM5
- UDI-DI: 00840311304363
- Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
- Expiration Date: 2027-11-30
- Quantity: 7 units
- Distribution: International distribution to India, Iran, Korea, and Saudi Arabia.
What You Should Do
Healthcare providers and facilities in the affected regions should immediately check their inventory for the serial numbers listed above. Affected units should be quarantined and not used for surgical procedures. Patients who have recently undergone implantation with this model should consult their eye care professional to monitor for symptoms of excessive vaulting or elevated eye pressure.
Why This Matters
The use of a lens with an incorrect length can lead to significant medical complications, including a reduction of irido-corneal angles, shallowing of the anterior chamber, elevated intraocular pressure (IOP), angle closure, and an unreactive pupil. In some cases, these issues may necessitate a surgical lens exchange or removal.
Source
Source: FDA Official Notice