Z-3049-2017 Class II Terminated
FDA device recall Z-3049-2017 was initiated by Alcon Research, Ltd. on June 30, 2017 and is designated Class II. Reason for recall: Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coeff… The recall status is terminated (terminated August 27, 2019). Affected quantity: 429 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2017
- Initiation Date
- June 30, 2017
- Termination Date
- August 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429 units
Product Description
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Reason for Recall
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
Distribution Pattern
Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom
Code Information
Serial numbers: C5013,C5014,C5015,C5016,C5017,C5018,C5019,C5020,C5021,C5023,C5024,C5025,C5026,C5027,C5028,C5029,C5030,C5031,C5032,C5033,C5034,C5035,C5036,C5038,C5039,C5040,C5041,C5042,C5043,C5044, C5045,C5046,C5047,C5048,C5049,C5050,C5051,C5053,C5054,C5055,C5059,C5060,C5061,C5062,C5064, C5065,C5066,C5069,C5071,C5075,C5076,C5077,C5078,C5079,C5080,C5081,C5082,C5083,C5090,C5093, C5094,C5097,C5098,C5101,C5102,C5105,C5106,C5107,C5108,C5109,C5110,C5111,C5112,C5113,C5116, C5117,C5119,C5120,C5121,C5122,C5125,C5126,C5127,C5128,C5129,C5130,C5131,C5132,C5133,C5134, C5136,C5137,C5138,C5139,C5140,C5141,C5142,C5143,C5144,C5146,C5147,C5148,C5149,C5150,C5151, C5152,C5153,C5154,C5155,C5156,C5157,C5158,C5159,C5160,C5161,C5163,C5164,C5165,C5166,C5167, C5168,C5169,C5170,C5171,C5173,C5174,C5175,C5176,C5177,C5178,C5179,C5180,C5181,C5182,C5183, C5184,C5185,C5186,C5187,C5188,C5189,C5190,C5191,C5192,C5193,C5194,C5195,C5196,C5197,C5198, C5199,C5200,C5201,C5202,C5203,C5204,C5205,C5207,C5214,C5215,C5216,C5217,C5218,C5219,C5220, C5221,C5222,C5223,C5224,C5225,C5226,C5227,C5228,C5229,C5230,C5231,C5232,C5233,C5238,C5239, C5240,C5241,C5242,C5243,C5244,C5245,C5246,C5248,C5249,C5250,C5251,C5252,C5253,C5255,C5256, C5257,C5258,C5259,C5260,C5261,C5262,C5263,C5264,C5265,C5266,C5267,C5268,C5269,C5270,C5271, C5272,C5273,C5274,C5276,C5277,C5278,C5279,C5280,C5281,C5282,C5283,C5284,C5285,C5286,C5287, C5288,C5289,C5290,C5291,C5292,C5293,C5294,C5295,C5296,C5297,C5298,C5299,C5300,C5301,C5302, C5303,C5304,C5305,C5306,C5307,C5308,C5309,C5310,C5311,C5312,C5313,C5314,C5315,C5316,C5317, C5318,C5319,C5320,C5321,C5322,C5323,C5326,C5328,C5329,C5330,C5334,C5335,C5336,C5339,C5340, C5341,C5343,C5348,C5349,C5350,C5352,C5353,C5354,C5355,C5356,C5357,C5358,C5359,C5360,C5361, C5362,C5363,C5364,C5365,C5366,C5368,C5369,C5370,C5371,C5372,C5373,C5374,C5375,C5376,C5377, C5378,C5379,C5380,C5381,C5382,C5383,C5384,C5385,C5386,C5387,C5388,C5389,C5390,C5391,C5392, C5393,C5394,C5395,C5396,C5397,C5398,C5399,C5400,C5401,C5402,C5403,C5404,C5405,C5406,C5407, C5408,C5409,C5410,C5411,C5412,C5413,C5414,C5415,C5416,C5417,C5418,C5434,C5435,C5436,C5437, C5438,C5439,C5440,C5441,C5442,C5443,C5444,C5446,C5448,C5449,C5451,C5452,C5453,C5454,C5456, C5458,C5462,C5463,C5464,C5465,C5466,C5467,C5469,C5471,C5473,C5475,C5476,C5477,C5478,C5479, C5484,C5485,C5486,C5487,C5488,C5489,C5490,C5493,C5494,C5495,C5496,C5497,C5499,C5500,C5501, C5502,C5503,C5507,C5508,C5509,C5510,C5511,C5512,C5515,C5516,C5517,C5518,C5519,C5520,C5521, C5522,C5524,C5525,C5526,C5527,C5528,C5529,C5530,C5532,C5533,C5534,C5535,C5536,C5537,C5538, C5539,C5544,C5545,C5546,C5547,C5549,C5550,C5553,C5555