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Urgent Enforcement Removed Final

Product Recall: Artis PL E and Artis Symbiose Intraocular Lenses

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Detected March 19th, 2026
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Summary

The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for Artis PL E and Artis Symbiose intraocular lenses manufactured by Cristalens Industrie. This safety action, registered under number R2606056, requires healthcare facilities to take immediate action regarding the affected lots.

What changed

The ANSM has issued a safety alert regarding a product recall of Artis PL E and Artis Symbiose intraocular lenses, initiated by Cristalens Industrie. The recall is identified under ANSM safety action number R2606056. Healthcare facilities that received the associated notification letter are directly involved in this action.

Healthcare providers must immediately cease use of the affected intraocular lenses and follow the instructions provided by Cristalens Industrie. While no specific compliance deadline is stated, the nature of a product recall implies an immediate need for action to prevent patient harm. Further questions should be directed to the manufacturer.

What to do next

  1. Cease use of affected Artis PL E and Artis Symbiose intraocular lenses.
  2. Consult the notification letter from Cristalens Industrie for specific instructions.
  3. Direct any questions to Cristalens Industrie.

Source document (simplified)

A+ A-

Rappel n° R2606056 destiné aux établissements de santé L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Cristalens Industrie.
Les établissements de santé concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606056.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Cristalens Industrie (19/03/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2606056

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Product Recall Medical Device Distribution
Geographic scope
France FR

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Healthcare

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