Alcon Research, Ltd.: Medical Device Recall in 2015 - (Recall #: Z-2323-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

Product Classification:

Class I

Date Initiated: April 15, 2015

Date Posted: August 19, 2015

Recall Number: Z-2323-2015

Event ID: 71630

Reason for Recall:

There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

Status: Terminated

Product Quantity: 45,391

Code Information:

Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Distribution Pattern:

Distribution Japan, No US distribution.

Voluntary or Mandated:

Voluntary: Firm initiated