It was reported that a laser vision correction patient had surgery on (b)(6) 2017 and presented on (b)(6) 2018 with extreme light sensitivity in both eyes that began about 1 month previously.Patient having trouble seeing computer screen and phone causing watery eyes and light sensitivity.The topical steroid dosage was increased.It was stated that the patient had no loss of best corrected visual acuity (bcva).Patient complained of transient light sensitivity syndrome.Reported symptoms are not interfering with patient¿s daily activities.Bcva from (b)(6) 2017: right eye pre-op 20/20 -4.00 x -.25 x 25, left eye pre-op 20/20 -4.00 x -1.25 x 160.Bcva from (b)(6) 2018: right eye post-op 20/15.25 x -.25 x 100, left eye post-op 20/15.25 x.00 x 90.
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Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson, vision has been submitted.
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