Home / Recalls / Abbott Medical Optics Inc. (AMO) / Z-2062-2017

Z-2062-2017 Class II Terminated

Recalled by Abbott Medical Optics Inc. (AMO) — Santa Ana, CA

Recall Details

Product Type
Devices
Report Date
May 17, 2017
Initiation Date
April 1, 2017
Termination Date
November 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
293,867 units total

Product Description

Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

Reason for Recall

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Distribution Pattern

US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador

Code Information

UB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533

Other recalls by Abbott Medical Optics Inc. (AMO)

  • Z-2064-2017 Class II — Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 (April 1, 2017)
  • Z-2063-2017 Class II — Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 (April 1, 2017)
  • Z-2067-2017 Class II — Healon V, Part No. 10290045 (April 1, 2017)
  • Z-2065-2017 Class II — Healon 5 Pro, Part No. 10270015 (April 1, 2017)
  • Z-2066-2017 Class II — Healon Pro, Part No. 10270012 (April 1, 2017)
  • Z-2096-2017 Class II — AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter (March 30, 2017)
  • Z-2857-2016 Class II — TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ind (August 26, 2016)
  • Z-2863-2016 Class II — TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The produc (August 26, 2016)
  • Z-2859-2016 Class II — TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is (August 26, 2016)
  • Z-2862-2016 Class II — TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Mod (August 26, 2016)