Vistakon
FDA adverse event reports naming Vistakon as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: VISTAKON.
- Total reports
- 1,217
- Deaths
- 0
- Injuries
- 1,154
- Malfunctions
- 1
Reports per year
Source: FDA adverse event reports by year received, 2001–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2010-09-21TerminatedError in labeling
Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper f
- 2009-09-18TerminatedOther
Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.
Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.
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