A sample was not received at the manufacturing site for evaluation for the report of fragmentation tip broken in the cataract lens during surgery; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; however, since the complaint report stated the fragmentation tip was used in several procedures and per the direction for use fragmentation tips are single use components, the root cause is use error.The exact root cause for this complaint is unknown and a review of the report description and complaint form revealed the fragmentation tip was used in several procedures, per the direction for use fragmentation tip are for single use; therefore, specific action with regards to this complaint cannot be taken.All fragmentation tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.The manufacturer internal reference number is: (b)(4).
|