|
Model Number DFW150 |
Device Problems
Break (1069); Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/28/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the intraocular lens (iol) had been released with its trailing haptic stretched and its haptic had been damaged when implanted.The lens was removed after being partially implanted with its optical part.The reporting physician had not had a feeling of resistance when it was implanted and the setting was conducted as per the instructions as usual.There was no patient injury and no further information was provided.
|
|
Manufacturer Narrative
|
Section a2, a4 and a5: unknown, as information was requested but not provided.Section d6a - implant date: implant date does not apply because the lens was removed during the same procedure.Section d6b - explant date: explant date does not apply because the lens was removed during the same procedure and has never been implanted.Section e1 - telephone number:(b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
|
Manufacturer Narrative
|
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: jul 18, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced and with a detached haptic stuck in the cartridge as well as overridden by the plunger rod.Inspection of the cartridge and lens module revealed that the handpiece was received with viscoelastic residue dispersed throughout the cartridge, suggesting that an adequate amount of ovd (ophthalmic viscoelastic device) was used.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The detached haptic was removed from the cartridge and the entire lens was cleaned, revealing that the lens was cut in half and that both haptics were detached (one missing).The complaint issue of haptic detached was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issues of delivery issue and trailing haptic not folded were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
|
Search Alerts/Recalls
|
|
|