Model Number AR40E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vitreous Loss (2142); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/20/2022 |
Event Type
Injury
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Event Description
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It was reported that the surgeon started to implant the intraocular lens (iol) but had to perform an unplanned vitrectomy due to vitreous in the anterior chamber.During the surgery the incision was enlarged to 6mm and a 10-0 nylon suture was used.A non- johnson and johnson iol was then implanted into the eye.No additional information was provided.
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Manufacturer Narrative
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If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Additional information: information was received confirming that there was vitreous in the anterior chamber (ac), an anterior vitrectomy was performed.Additional information received that it was unknown if there was capsule tear.An anterior chamber (the non johnson and johnson) lens was placed, malyugin ring was used.It was stated that the patient has a small pupil and a very mature cataract.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 7/8/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was coated in viscoelastic residue and debris.The lens was cleaned and, no issues could be identified with the lens.The complaint issue (pt-unplanned vitrectomy, hs-incision enlarged, pt-sutures, and hs-vitreous in the anterior chamber) was not confirmed.They could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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