Model Number VTICM5_13.2 |
Device Problems
Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Cataract (1766); Blurred Vision (2137); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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A4: weight unk.A5: ethnicity unk.A6: race unk.B3:event date unk.D4: expiration date unk.D6b: explant unk.H4: device manufacture date unk.H6: health impact- clinical code: 4581 - difficulty reading va.Claim # 432841.
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Event Description
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The reporter indicated the surgeon implanted an icl implantable collamer lens, into the patients left eye (os) on (b)(6) 2023.A cataract was observed and the patient complained of discomfort, blurred vision and difficulty reading va.The lens remained implanted but the plan was to remove the lens.Additional information has been requested but none has been forthcoming.
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Manufacturer Narrative
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Additional data: h6 - work order search: no similar complaint was reported for units within the same lot.Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -10.50/+1.0/050 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to low vaulting.And lens opacity (anterior subcapsular) was observed.The patient complained of discomfort, blurred vision and difficulty ready va.The cause was unknown.D2: common device name: phakic toric intraocular lens, product code: qcb.Claim # (b)(4).
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Search Alerts/Recalls
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