Model Number VTICM5_13.2 |
Device Problems
Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endophthalmitis (1835); Blurred Vision (2137)
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Event Type
Injury
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Manufacturer Narrative
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This product is not marketed in the us.No similar complaint type events reported for units within the same lot.Claim # (b)(4).
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Event Description
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A 13.2mm vticm5_13.2 implantable collamer lens -10.5/+2.5/093 (sphere/cylinder/axis) was implanted into the patient's left (os) eye.The surgeon reports endophthalmitis after one week of surgery.Treatment was provided, the lens was explanted.Vitreoretinal injection and other medication was given.The problem is resolved.
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Manufacturer Narrative
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B5-additional information: the lens was initially implanted (b)(6) 2021.The lens was explanted (b)(6) 2021.Additional symptom of blurred vision reported.H6-device code 1494: (age<21yrs).Claim# (b)(4).
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Manufacturer Narrative
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H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).
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Search Alerts/Recalls
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