[188490321]
Brand name: unknown, as the serial number was not provided. Model number: unknown, as the serial number was not provided. Serial number: unknown, information not provided. Udi number: unknown, as the serial number was not provided. Catalog number: unknown, as the serial number was not provided. Expiration date: unknown, as the serial number was not provided. If explanted, give date: not applicable, as the lens remains implanted; therefore, it was not explanted. Initial reporter phone number, facility name, and address were not provided. Pma/510(k) #: unknown, as the serial number was not provided. Device manufacture date: unknown, as the serial number was not provided. The lens remains implanted. There was no model/lot/serial number reported for this device; therefore, no further investigation can be performed. If there is any further relevant information received, a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188490322]
It was reported in a masked clinical study that a patient was implanted bilateral intraocular lenses. During the 1st month visit the patient had very bothersome halos and starbursts. The 1 month best corrected visual acuity was right eye (od)-80, left eye (os)-87. However, at 6th month follow-up visit, the best corrected distance visual acuity (bcvda) are noted to be od-85, os-87 (ou) both eyes bcdva: 20/16) etdrs (early treatment diabetic retinopathy study) letters read. Moreover, the subject is still complaining of very bothersome halos and starbursts. There is no plan for surgical intervention. No other information was provided. This mdr report pertains to the right eye (od). A separate report will be submitted for the left eye (os).
Patient Sequence No: 1, Text Type: D, B5