[188270976]
Age/date of birth: unknown/ not provided. Common device name: unknown, information not provided. Model# and partial catalog#: unknown, as serial number was not provided. Serial number: unknown, information not provided. Unique device identifier (udi #): unknown, as serial number was not provided. Expiration date: unknown, as serial number was not provided. Device manufacture date: unknown as serial number was not provided. If explanted; give date: n/a (not applicable). Lens remains implanted. Device evaluation: the product was not returned as it remains implanted; therefore, the complaint issue reported was not verified. Manufacturing records review: the manufacturing record cannot be reviewed since the serial number is unknown. Historical data analysis: the complaint history was not reviewed since the serial number is unknown. Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188270977]
The customer account reported of an uneventful with the zxt375 intraocular lens (iol) that was implanted in the patient's operative eye on (b)(6) 2020. At 1 day post-op, the lens was well aligned. Patient's vision screening 20/50. Patient returned for 1 week post-op visit and complaining of triple vision. The lens is perfect but looks to be rotated about 30 degrees counter clockwise from original location. Patient reported shield shifted one night when he was sleeping with operative eye in pillow. The surgeon thinks shield pressed on paracentesis site causing lens to shift. Left eye lens zxt375 +15. 5 d at an axis of 166. Axial length: 24. 96. K os flat: 44. 00@74. K os steep: 46. 50 @ 164. Sia 0. 20 @ 90. Immersion. A constant: 119. 3. There is no plan for lens exchange at this time. No further information provided.
Patient Sequence No: 1, Text Type: D, B5