[188723673]
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Date of event: unknown, not provided. If implanted, give date: not applicable as this is not an implantable device. If explanted, give date: not applicable as this is not an implantable device. (b)(6). (b)(4). This complaint is part of the recall - report number 2020664-12/02/19-001-r: johnson & johnson surgical vision (jjsv) issued a voluntary recall on november 22, 2019. It has been reported customers have described healon gv pro as behaving differently than the legacy healon gv, especially in regard to the techniques required to remove the product from the eye. An increase of intra-ocular pressure (iop) is reported if there are small amounts of healon gv pro remaining behind the operative eye. This voluntary recall is being initiated due to received reports of healon gv pro being difficult to remove from the eye, leading to increased post-operative iop requiring additional intervention. Potential clogging of phacoemulsification equipment tubing has also been reported, which may lead to delay in the procedure or ocular injury. There are twenty-one affected lot numbers. The recall notification letter has been sent to all customers instructing them to return the units of healon gv pro from the twenty-one (21) affected lots. Johnson & johnson surgical vision has initiated a corrective and preventative actions (capa) to investigate and address the issue. Action items generated from the capa will be submitted in the future interim report(s) as part of the recall process. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188723674]
It was reported that there was severe ocular hypertensive crisis, paralytic right eye mydriasis and campimetric alteration in post-op. No further information provided.
Patient Sequence No: 1, Text Type: D, B5