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Pentacam axl

Official notice

25 Jul 2022

Last checked

25 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Pentacam axl. During post-market surveillance, we have found that the IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs. The information displayed directly in the software is correct. Recall start date: le 8 juillet, 2022 Published 2022-07-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64400

Official notice

2022-07-25

The hazard

During post-market surveillance, we have found that the IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs. The information displayed directly in the software is correct. Recall start date: le 8 juillet, 2022

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64400

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Affected products

Product 1

Affected lots - Pentacam Axl, Lot or serial number - 70100 0931 7150 70100 5261 7121 70100 3032 1270 70100 0831 7150 70100 9891 9170 70100 7881 9120, Model or catalogue number - 70100

Risk / hazard

During post-market surveillance, we have found that the IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs. The information displayed directly in the software is correct. Recall start date: le 8 juillet, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Oculus Optikgeraete, Pentacam Axl.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64400

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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