[188721624]
Age/date of birth: unknown/ not provided. Lot number # : unknown. Expiration date : unknown as lot number is unknown. If implanted, give date: not applicable, as viscoelastic healon is not an implantable device if explanted, give date: not applicable, as viscoelastic healon is not an implantable device. (b)(6). Device manufacture date: unknown as lot number is unknown. (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
[188721625]
It has been reported issues with viscoelastic, model healon gv pro. Patient's lawyer has reported that patient's is dissatisfied with the outcome after surgery. The patient underwent a cataract surgery on (b)(6) 2019 and after the surgery, the patient allegedly experienced pain, intraocular tension and loss of sight of the left eye. Since then, the patient has allegedly attended periodic reviews. Patient was treated and at the end of december had the pain stopped and the intraocular tension was normalised but the left eye sight has not been recovered. All the information available were submitted.
Patient Sequence No: 1, Text Type: D, B5