[186752228]
(b)(4). Device evaluation: the product was returned to the manufacturing site wrapped in medical dressing placed inside a biohazard resealable bag. A visual inspection with the unaided eye revealed the lens was returned in one piece with lint fibers on surface. Lens was cleaned with purified water and dried with compressed air to ease inspection. Further inspection under 12x magnification revealed fiber and residue remains visible on iol surface. Scratches and abrasions were visible on lens surface. None of these cosmetic issues will impact the mechanical behavior of the lens. The complaint issue reported was not verified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. Historical data analysis: a search of complaints revealed no other complaints have been received for this production order. 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
[186752229]
It was reported that a zlb00 intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2018. It was later explanted on (b)(6) 2019 due to mechanical failure. At 1 week postop, patient reported symptoms of cloudy, fuzzy, blurred vision at distance and near, and glare with night driving. A refraction was performed and the symptoms could not be resolved with prescription lenses. The patient was not adapting to the multifocal implant. Pre-ops best corrected visual acuity (bcva) was 20/40 at distance and j2 at near, bat glare testing 20/400. Post-ops bcva is 20/30 distance vision and j1 near vision. Reportedly, the patient's vision is great now. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5