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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Recall Number Z-1445-2014
Classification Class II
Code Info (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.
Product Distributed Qty 75
Reason For Recall Alcon LenSx received reports of unexpected downward motion of the gantry.

Event Detail

Event Id 67755
Product Type Devices
Status Ongoing
Recalling Firm Alcon LenSx, Inc.
City Aliso Viejo
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution.