Model Number CNA0T0 |
Device Problems
Malposition of Device (2616); Scratched Material (3020); Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
An other health care professional reported that lens was stuck inside the applicator, lens was also scratched.According to additional information, the lens tore and became caught in the conjunctive during insertion, and it also suffered damage after being removed from the wound.The lens was removed and replaced with another company lens in an initial procedure.There was no patient harm.
|
|
Manufacturer Narrative
|
The product was returned for analysis.Additional information: the complainant indicates the use of non company viscoelastic, which is not qualified for use with company suspect device.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The returned sample is not the actual complaint unit.Sample of a different serial number was returned.No clarification was received from the complaint.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|