Model Number SOFHDPLI+20.0D AND PLITIP1645 KIT |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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Patient Problem
Corneal Edema (1791)
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Event Date 02/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.
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Event Description
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Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".
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Manufacturer Narrative
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A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Additionally, no other complaints have been received from this batch.The investigation of the device indicates that the damage on the lens was due to surgical manipulation and removal from the eye (lens was cut).Furthermore, all lenstec's devices are 100% inspected and if damages were present the device would have been rejected.Moreover, lenstec ensures though previous validations, that if the instruction for use are followed, the lens will be implanted without damage.
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Event Description
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Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".
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Search Alerts/Recalls
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