Device Problems
Misfocusing (1401); Optical Problem (3001)
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Patient Problems
Vitreous Floaters (1866); Intraocular Pressure Increased (1937); Pain (1994); Retinal Detachment (2047); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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B3:unk.D4: expiration date unk.D6b: unk.E3: unk.H4: unk.H6: health impact- clinical code: 4581 - reduced va, dysphotopsias, refractive error.H6: health impact - additional surgery: 4625 - addition of laser peripheral iridotomy (lpi).Claim # (b)(4).
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Event Description
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The patient reported the surgeon implanted an icl implantable collamer lens in her right eye (od), on (b)(6) 2023.On (b)(6) 2023, the patient had sudden and painless loss of vision.The patient went to hospital and was treated for high intraocular pressure.On (b)(6)2023 the surgeon performed laser peripheral iridotomies (lpi).The patient reported reduced visual acuity, permanent dysphotopsias, glare/halo, significant refractive error and pain.The reporter indicated the cause of the event was due to the laser peripheral iridotomies (lpi) the surgeon had performed post-op.Post-op the patient had retinal detachments and floaters.The lens remained implanted.Additional information has been requested but none has been forthcoming.
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Manufacturer Narrative
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Additonal information: b5 - patient also experienced blurred vision and discomfort.Corrected data: b5 - posterior vitreous detachment should be removed.H6 - code 1994 -pain, should be removed.H6- code 2047 - retinal detachment, should be removed.Claim #: (b)(4).
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Search Alerts/Recalls
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