Model Number DCB00 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Intraocular Pressure Increased (1937); Vitreous Loss (2142); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient weight: unknown as information was asked but it was not provided.Date of event: unknown/not provided, but the best estimate date is during (b)(6) 2022.Initial reporter telephone number: (b)(6).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 & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported that a patient implanted with a one piece preloaded intraocular lens (iol), model dcb00 with 19.0 diopter power, came back the next day for an emergency procedure on the operated eye.Account indicated that the iol superonasally displaced with vitreous in the anterior chamber.A 3-piece lens (model za9003 with 18.5 diopter power) was placed as the replacement iol.Incision enlargement was required, and sutures and vitrectomy were performed.The intraocular pressure (iop) noted as high at the start of the surgery was well controlled post patient discharge.Diamox 250 mg and simbrinza were prescribed by the doctor outside of the normal post-operative treatment.The explanted iol is not available for investigation.No further information received.
|
|
Manufacturer Narrative
|
Corrected data: upon further review the initial mfr report number 3012236936-2022-01922 should have included that the event is both an adverse event and a product problem.Therefore, the current report captures this correction: section b1 - report type: product problem.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Search Alerts/Recalls
|
|