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U.S. Department of Health and Human Services

Class 2 Device Recall IOLMaster 500

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  Class 2 Device Recall IOLMaster 500 see related information
Date Initiated by Firm October 23, 2013
Date Posting Updated November 15, 2013
Recall Status1 Terminated 3 on April 17, 2014
Recall Number Z-0334-2014
Recall Event ID 66635
510(K)Number K993357  K101182  K122418  
Product Classification Biomicroscope, slit-lamp, ac-powered - Product Code HJO
Product Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,

Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA

This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
Code Information 086809, 1086811, 1086813, 1086815, 1086816, 1086817, 1086818, 1086819, 1086820, 1086821, 1086846, 1086848, 1086850, 1088220, 1088221, 1088225, 1088292, 1088296, 1088297, 1088299, 1088321, 1088322, 1088324, 1089272, 1089273, 1089276, 1089277, 1089278, 1089279, 1089280, 1089281, 1089285, 1090583, 1090585, 1090586, 1090589, 1090593, 1090594, 1090595, 1090596, 1092632, 1092633, 1092634, 1092635, 1092636, 1092638, 1092639, 1092640, 1092683, 1092686, 1092688, 1092690, 1092692, 1092702, 1094030, 1094032, 1094033, 1094034, 1094035, 1094039, 1094044, 1094046, 1094048, 1094049, 1094050, 1094051, 1094053, 1094054, 1094056, 1094057, 1094058, 1094060, 1094061, 1094062, 1094063, 1094064, 1094065, 1094066, 1094067, 1094068, 1094069, 1094071, 1094072, 1094074, 1094075, 1094076, 1095354, 1095356, 1095357, 1095358, 1095360, 1095361, 1095362, 1095364, 1095365, 1095366, 1095375, 1095378, 1095389, 1095390, 1095392, 1095822, 1095823, 1095824, 1095826, 1095827, 1095833, 1095834, 1095835, 1095836, 1095837, 1095838, 1095839, 1095841, 1097061, 1097063, 1097066, 1097068, 1097069, 1097074, 1097075, 1097077, 1097078, 1097079, 1097081, 1097084, 1097088, 1097090, 1097091, 1097092, 1097096, 1097660, 1097661, 1097662, 1097663, 1097664, 1097665, 1097666, 1097678, 1097684, 1097685, 1097686, 1097687, 1097689, 1097691, 1097694, 1097699, 1098281, 1098282, 1098285, 1098286, 1098287, 1098294, 1098295, 1098299, 1098303, 1098305, 1098311, 1098795, 1098797, 1098798, 1098801, 1098802, 1098804, 1099560, 1099568, 1099569, 1099571, 1099572, 1099575, 1099588, 1099592, 1099594, 1100687, 1100688, 1100689, 1100690, 1100720, 1100723, 1100724, 1100725, 1100726, 1100728, 1100729, 1101675, 1101704, 1101706, 1101711, 1101713, 1101714, 1101715, 1101716, 1101717, 1101723, 1101724, 1102075, 1102078, 1102080, 1102081, 1102082, 1102083, 1102084, 1102085, 1102086, 1102087, 1102092, 1102093, 1102095, 1102099, 1103003, 1103005, 1103006, 1103007, 1103008, 1103011, 1103019, 1103020, 1103021, 1103022, 1103024, 1103025, 1103035, 1103036, 1103037, 1103038, 1103039, 1103040, 1103041, 1104998, 1105001, 1105002, 1105003, 1105004, 1105005, 1105007, 1105603, 1105604, 1105605, 1105606, 1105607, 1105608, 1105609, 1105610, 1105611, 1105612, 1105626, 1105627, 1105630, 1105634, 1105635, 1105895, 1105896, 1105898, 1105900, 1105901, 1105902, 1105903, 1105904.
Recalling Firm/
Manufacturer
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact Judith A. Brimacombe, M.A.
925-557-4616
Manufacturer Reason
for Recall
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
FDA Determined
Cause 2
Software in the Use Environment
Action The firm, Zeiss, sent an "Urgent Medical Device Correction" letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to immediately update the Laser Interference Biometry (ULIB) lens constants, provided as an Attachment 1 and complete and return Attachment 2- Confirmation Form via mail to: Stericycle, Inc., 6026 Lakeside Blvd., Indianapolis, IN 46278; Attn: Zeiss IOLMaster. If you have any questions, call the following number for assistance: 1 (866) 891-1922.
Quantity in Commerce 1,201 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HJO and Original Applicant = CARL ZEISS MEDITEC AG
510(K)s with Product Code = HJO and Original Applicant = CARL ZEISS, INC.
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