Lenses, Soft Contact, Extended Wear
FDA adverse event reports and recall history for lenses, soft contact, extended wear (product code LPM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,051
- Deaths
- 0
- Injuries
- 2,936
- Malfunctions
- 42
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-07-23Open, ClassifiedUse error
Biofinity XR Toric Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- 2025-07-23Open, ClassifiedUse error
Biofinity Toric Multifocal Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- 2024-09-30Open, ClassifiedProcess control
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
- 2024-09-30Open, ClassifiedProcess control
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
- 2023-03-01Open, ClassifiedEmployee error
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- 2023-03-01Open, ClassifiedEmployee error
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- 2020-01-27TerminatedProcess control
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Incorrect power of lenses than the expected
- 2020-01-27TerminatedProcess control
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
Incorrect power of lenses than the expected
- 2015-01-12TerminatedMaterial/Component Contamination
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.
- 2015-01-12TerminatedMaterial/Component Contamination
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) Product Usage - Eye contact lens
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.
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