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This event represents an extraordinary and unlikely set of circumstances, the probability of which cannot realistically be reduced by the manufacturer.The model of frames allegedly at issue in this event are composed of a flexible polymer.This material increases the frames' durability and comfort for use by children.This flexibility may slightly increase the risk of a lens being removed from the frame if a lens is not appropriately edged and mounted by the prescription laboratory, or if the user applies significant force to the lens.However, the frames' flexibility is a valuable design feature for spectacles used by children to reduce breakage and associated risks and increase comfort.A more rigid material would result in an overall reduction in functionality with an expected increase in risk of harm (as discussed below).One key benefit of the frames' flexibility is resistance to breaking, which could injure a child.Some broken rigid frames may contain sharp edges resulting in cuts, lacerations or other injuries to the face or extremities.The miraflex flexible frames material, even if broken, provide no potential harm or injury to children's faces.Another benefit of flexible frames for children's use is improved comfort, including the ability to adjust (stretch) to growing faces.This improves rates of use of corrective lenses.Thus, the use of a flexible frame results in improved health outcomes.Miraflex reviewed its records for the past 20 years and identified no other reported cases of spectacle lenses removed and swallowed by juveniles or any other users.Miraflex has no record of any damages or harm caused by its flexible frames worldwide.The risk of choking or aspirating a spectacle lens of these dimensions pulled from a frame is simply too improbable to have been considered in normal risk assessment.Depending on the materials used in the spectacle frames, and the way lenses are edged and ultimately mounted in the frames, lenses may fall out or be pushed out based on strong force applied to the lenses (so the ability to remove a lens is conditional on the age or physical condition of the user).But any lens that can be inserted can ultimately be removed regardless of the type of frame.Selection of different frame materials, or design, might slightly reduce, but not eliminate, the risk of lens removal, providing only minimal protection to the already low risk based on the selection of material.The de minimis reduction in risk of lens removal would be more than offset by the increased risk of other adverse health outcomes associated with use of rigid material in frame design.There exists an increased risk of injury from broken rigid frames, even though in general, all frames are made of plastic injected materials with very low risk of harming any user (adult/child) if broken (as evidenced by the almost nonexistent record of consumer complaints related to harms caused by frames worldwide).Therefore, the small increased risk of a lens separating from a flexible frame is considered acceptable.Without inspecting the lenses as they were inserted into the frame by the prescription laboratory retained by the optical shop, we are unable to determine whether installation (edging and mounting as referenced above) may have increased the risk of lens separation during normal use.We are also unaware of the potential misuse by (b)(6) while user error and appropriate faculty supervision were concluded to be the cause to this injury, we are confident that our labeling remains sufficient to direct prescription laboratories in the proper edging and mounting of the lenses in the frames.Based on the manufacturing process, absence of similar complaints, and the unique set of circumstances that must have come into play for (b)(6) to be seriously injured, we presume that the primary contributing factor in this incident is likely end-user misuse of the frames.Manipulation of the frames is a type of misuse expected from a young child.But the force to remove a properly installed lens from the spectacle frame is larger than would be expected from a young child.Aside from damaging these eyeglasses and preventing their proper use, there is little additional harm anticipated from this misuse.As noted above, altering the frame design to make it more difficult to remove the lenses through use of more rigid materials would diminish their utility in juvenile populations.A user over the age of two forcing an ophthalmic lens down his/her throat is a misuse that is not readily predictable.It is very unlikely to happen and it would be very difficult to recur considering lenses generally have a significant size and are not appealing as food based on taste or smell.Such extraordinary misuse is sufficiently rare and cannot be avoided through more careful design or manufacture.Nevertheless, we are considering the addition of additional safely warnings, to the extent such warnings would be effective and appropriate.
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This narrative is based on a third-party report, the accuracy of which miraflex has not yet been able to confirm.(b)(6), a (b)(6) year old boy, suffers from a "rare genetic disorder" affecting his cognitive abilities.(b)(6) was prescribed corrective spectacle lenses.(b)(6)'s mother, (b)(6), purchased miraflex flexible children's frames [reportedly a newbaby 4 model] from an optical shop owned by (b)(6) hospital located at (b)(6).While at school on (b)(6) 2019, (b)(6) reportedly removed one ophthalmic lens from his spectacle frame and swallowed it.The lens reportedly migrated down his windpipe and ultimately into his lung.(b)(6) was hospitalized and intubated twice with labored breathing.On (b)(6), the ophthalmic lens was discovered in (b)(6)'s lung and removed.
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