# FDA recall Z-0581-2026

> **Alcon Research LLC** · Class II · device recall initiated 2025-09-15.

## Product

CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:  25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/	8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/	8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/	8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/	8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/	8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/	8065752417; TOTAL PLUS,23G,10K VALVE STD/	8065752435; TOTAL PLUS,23GA,10K VALVE WD/	8065752436; TOTAL PLUS,25+,10K VALVE STD/	8065752437; TOTAL PLUS,25+,10K VALVE WD/	8065752438; TOTAL PLUS,27+,10K VALVE STD/	8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/	8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/	8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/	8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/	8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/	8065752452; 25+TTLPL VPK 20000CPM BEV VAL/	8065753106; 27+TTLPL VPK 20000CPM BEV VL/	8065753109; HYPERVIT 25+BEV 20000 CPM/	8065830026; HYPERVIT 27+BEV 20000 CPM/	8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/	8065830077; 25G VIT 25

## Reason for recall

XXX

## Distribution

Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND, HI, ME, IA, MS, NV, OK, WV, VT and the countries of GB, CA, IE, CH, JP, AT, CZ, GR, HU, PL, TR, ZA, MU, ZM, SA, IL, KW, BD, UZ, LB, LV, AZ, MN, IR, MK, VN, MT, AE, ID, CY, MD, RS, QA, LK, DZ, EG, TN, BG, OM, HR, KH, IT, NL, LU, BE, JO, BH, ES, PT, FI, SE, DK, IS, RO, RU, UA, DE, FR, MQ, AU, NZ, HK, MO, SG, PH, PF, GF, GP, NC, RE, KR, IN, TH, TW, MY, BN, CN, IQ, SI, MA, CL, EC, MX, PE, PK, AR, BR, CO, UY, JM, BS, DO, TT, GT, CR, BB, AW, SK, KZ, BY, AM, SV, SR, KG, UG, PA, NI, PY, HN.

## Key facts

- **Recall number:** Z-0581-2026
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-15
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2026

## Citation

> AI Analytics. FDA recall Z-0581-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0581-2026. Source: US FDA. Licensed CC0.

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