🔍 RecallPedia

Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

Class I - Dangerous
🏥 Medical Devices Recalled: March 14, 2014 Alcon LenSx Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    (US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Alcon LenSx, Inc.
Reason for Recall:
Alcon LenSx received reports of unexpected downward motion of the gantry.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

Product Codes/Lot Numbers:

(US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1445-2014