The device was not available to be returned for evaluation.The device history and sterilization records were reviewed and found to meet manufacturing specifications.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.(report 2 of 3; see also 0001920664-2021-00024 & 0001920664-2021-00026) on (b)(6) 2021, bausch + lomb received an email from (b)(6) at cdrh/food and drug administration notifying the company that the report initially submitted on (b)(6) 2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.
|
A user facility in (b)(6) reported that, during surgery, the hospital opened the disposable pack and found the light pipe''s optical fiber was broken and the illumination was not bright.The hospital opened another pack and used products from both packs to complete the operation.The surgery was prolonged approximately two hours but no additional anesthesia was required.No medical intervention or treatment was required and the patient was discharged from the hospital.
|