Model Number VTICM5 13.2 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
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Patient Problems
Intraocular Pressure Increased (1937); Blurred Vision (2137)
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Event Date 01/24/2024 |
Event Type
Injury
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Manufacturer Narrative
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H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
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Event Description
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The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -10.00/3.5/167 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault;elevated iop and blurred vision was reported.The lens remains implanted.Eye drops prescribed.At one week post op patient is doing well and healing.If additional information is received a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Corrected to: "the reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -10.50/3.5/167 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault;elevated iop and blurred vision was reported.The lens remains implanted.Eye drops prescribed.At one week post op patient is doing well and healing.If additional information is received a supplemental medwatch report will be submitted." in the initial mdr.Claim #(b)(4).
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Search Alerts/Recalls
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