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Recall Observatory FDA recall evidence

Device product

Prescription eyeglass safety lenses. Vision correction

Z-0167-2015

September 12, 2014

Class II

Product summary

Firm
Eyemart Express Ltd
Event
Event 69345
Status
Terminated
Classification
Class II
Quantity
76 pairs of eyeglasses
Official record key
device-enforcement:Z-0167-2015

Official wording

Reason: Prescription eyeglass safety lenses did not meet specifications.

Code information: No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28

Distribution pattern: Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Prescription eyeglass safety lenses did not meet specifications.