Catalog Number CBV92001360 |
Device Problems
Difficult to Remove (1528); Torn Material (3024)
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Patient Problems
Corneal Abrasion (1789); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231); No Code Available (3191)
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Event Date 07/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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This is the second of the two reports for the same patient involving two lot numbers of the same product.Refer to (b)(4) for the reported lot number a0491511.The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).
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Event Description
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It was initially reported by a female patient via telephone that the contact lens was torn in her eye and it was difficult to remove.The patient experienced tearing, pain and eye redness while trying to remove the lens.Medical attention was sought to remove the contact lens and the eye care provider (ecp) saw a deep corneal scratch after removing the contact lens in the right eye.The patient was given ofloxacin eye drops taken several times a day for five days.Further information was received per doctor's examination that the patient's right eye had a deep scratch on the regular chamber and was diagnosed with re conjunctival foreign body corneal erosion due to contact lens but there were no signs of infection.The patient's pupil was round and reactive but the patient's eye recovery remained unknown.Further information was received via telephone on (b)(6) 2017 that the patient's eye was completely recovered.
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Manufacturer Narrative
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Removed other remedial action value "unknown" from previously submitted regulatory report/s.The manufacturer internal reference number is: 2017-64708.
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Search Alerts/Recalls
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