Model Number MN60AC |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Iritis (1940); Blurred Vision (2137); Visual Disturbances (2140); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
|
Event Date 06/30/2023 |
Event Type
Injury
|
Event Description
|
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had blurry vision and glare.The iol was exchanged for unspecified monofocal lens.Clinical reason for explant mentioned as mechanical complication of iol.Additional information has been requested, received and stated the lens dislocated causing chronic iritis.The patient had uveitis glaucoma hyphema (ugh).The iol was exchanged for another model company lens of different diopter.
|
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of non-qualified associated cartridge, handpiece and viscoelastic.The current company model lens is only qualified for use in the appropriate company cartridges.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the current company 18.5 diopter lens was replaced with another model company, 19.0 diopter lens due to the report of the lens becoming dislocated and causing chronic iritis.The product has not been received to evaluate.Information about the cause of the dislocation was not provided.The lens was implanted for three years before being explanted.It was reported that the patient's issue have resolved post exchange.No further information has been provided at this time.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|