If explanted, give date: not applicable as there is no indication the lens has been explanted.(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaint was received from this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
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After implantation of zcb00 iols in a female patient's right and left eye; the patient's vision is pitch black and takes a long time to focus and adjust to the inside light of her home.Furthermore, the patient reports her eyes really bother her as she also has dry eyes, and was told to use artificial tears.The patient also indicated that she has more problems with her right eye than her left eye.The patient provided additional information and reports she was diagnosed right after the cataract surgeries with macular degeneration in her left eye.Her right eye is fine.When she enters a room where a light is not on, she is unable to see anything, it's like she is blind.She indicates it is ''horrible''.She can read, watch tv, and only drives short distances.Patient is currently being seen by other doctors who are treating her macular degeneration.Patient reports the dark/blind effect she experiences is in both eyes.She denies having these conditions or symptoms prior to the cataract surgery.This report will capture the zcb00 21.5 diopter intraocular lens (iol) implanted in the right eye and a separate mdr will be filed for the lens zcb00 implanted in the left eye.No further information was provided.
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