LIFECORE BIOMEDICAL, LLC VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC
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Catalog Number 0004520066 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Intraocular Pressure Increased (1937); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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No sample has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that viscoelastic solution was used during surgery after which the patient presented, postoperatively, with unusual findings including possible toxic reaction, unspecified, and elevated intraocular pressure.The patient was surgically treated with two angle taps.Additional information has been requested.
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Manufacturer Narrative
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Additional information is provided in sections d.4, h.4, h.6 and h.10.A complaint sample was not received for evaluation.Complaint trending was reviewed for the lot code provided and no similar complaint was found.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during the batch record review.All product testing met specification for both in-process and final release.This report is consistent with known potential reactions observed in the use of ophthalmic viscosurgical devices and is indicated in the instructions for use.A root cause could not be determined.This report is consistent with known potential reactions observed in the use of ophthalmic viscosurgical devices and is indicated in the instructions for use.Based on the investigation, the lack of additional complaints for this lot and the acceptable batch record review, no further actions are warranted at this time.The manufacturer internal reference number is: (b)(4).
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