Recall Z-3313-2024— Alcon Research LLC
Class II · Ongoing
Class II FDA medical device recall by Alcon Research LLC, initiated 2024-08-08. It names 2 FDA 510(k) clearances: K233856, K232921. Product: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,. Reason: Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
- K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Reason for recall
Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
Data sourced from openFDA. This site is unofficial and independent of the FDA.