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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