Model Number AQ5010V |
Device Problems
Off-Label Use (1494); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Corneal Decompensation (1790); Corneal Edema (1791); Macular Edema (1822); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Manufacturer Narrative
|
Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide).(b)(4).
|
|
Event Description
|
The reporter indicated an aq5010v silicone three piece lens, +1.0 diopter, was implanted by another surgeon on (b)(6) 2019 as a piggy-back lens.The reporter indicated the aq5010v lens was explanted on (b)(6) 2020 by a different surgeon (facility), due to the primary lens had decentered and the haptic of the aq5010v had folded back.The lens was discarded.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
|
|
Manufacturer Narrative
|
B5: the piggyback iol was slightly decentered and one haptic was folded back on iol, which resulted in cme, corneal decompensation and corneal edema in right eye (od).Iol exchange and dsaek were performed.The reporter indicated the cause of the event was due to the placement of iol.The piggyback iol was placed behind the primary lens, was compressed within the bag and haptic was folded back on the iol.Post-op medication was prescribed.Post-op, patient reported vision is blurry but improving every day.H6: health effect impact code: 4625 - iol exchange and dsaek performed.Claim # (b)(4).
|
|
Search Alerts/Recalls
|