[187873374]
Date of event: unknown, not provided. Brand name: unknown as product serial number was not provided. Model number: model number is unknown, as product serial number was not provided. Catalog number: catalog number is unknown, as product serial number was not provided. Expiration date: unknown as product serial number was not provided. Serial number: unknown as the information was not provided. Udi number: udi # is unknown as product serial number was not provided. If explanted; give date: not applicable as the iol remains implanted in the patient's eye. Pma/510(k) number: unknown as iol product serial number information was not provided. The product serial number for this device is not available and the lens also remains implanted; therefore, no further investigation can be performed. If there is any further relevant information received, a supplemental medwatch report will be filed. Device manufacture date: unknown as product serial number was not provided. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187873375]
A male patient reported being implanted with a tecnis symfony intraocular lens (iol), in the right eye (od) on (b)(6) 2020 as the patient had astigmatism and his doctor thought this lens would be the best option. A few days post implant the patient felt his vision was not normal, and it did not feel well. The patient was also experiencing halo's and thought that the iol had moved. When he visited his surgeon, the patient was informed that lens had rotated. The patient did not know how many degrees the lens had rotated. It was indicated that the doctor performed a lens repositioning procedure on (b)(6) 2020. Reportedly, the doctor indicated that it was hard to rotate the lens as it was firmly in place, but he managed to reposition the lens. The patient was seen again on (b)(6) 2020 the doctor confirmed that the lens was in the correct position and in the right spot. On (b)(6) 2020, the patient reported that his eye was still dilated so he was not able to report about the outcome; however, his doctor told him that it was going to get better with time. The patient indicated that he was following his doctor's instruction with regards to using the medications (antibiotic and steroid and another medication) post lens repositioning in a timely manner. On (b)(6) 2020 the patient called back and reported experiencing some spider web issues with lights. The patient also reported noticing the rings of the lens and when he reported the issue to the surgeon, he was told that, he will get used to it which he has. The patient indicated that when he was initially implanted with the lens, one day post-op, his visual acuity (va) was 20/30, then after the lens moved/rotated, before the 2nd re-rotation procedure, his va was 20/80. Post lens re-rotation procedure, the patient cannot read at close range and cannot use the computer. The patient was given 1. 75 readers which have worked fine. The patient is to be seen by the surgeon for a post-op visit in march by the surgeon. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5