• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IOLMaster 500

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall IOLMaster 500 see related information
Date Posted November 15, 2013
Recall Status1 Terminated 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
925-557-4616
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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.
-
-