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Health product recall

IOL Master 700 (2015-02-04)

Starting date:
February 4, 2015
Posting date:
July 22, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59502

Affected products

A. IOL Master 700

Reason

The current IOLmaster 700 software version 1.14.84 sometimes shows an unexpected behavior during toric IOL power calculation with the haigis suite: in some cases of low cylinder power with a theoretically ideal IOL below the delivery range of the selected toric IOL model, the device suggests a toric IOL with significant remaining cylinder refraction.

Affected products

A. IOL Master 700

Lot or serial number

1128467
1128480
1131493
1131495
1131507
1131532
1131535
1131539

Model or catalog number

IOL MASTER 700
 

Companies
Manufacturer
Carl Zeiss Meditech AG
Goeschwitzer Strasse 51-52
Jena
07745
GERMANY