ENVISTA SIMPLIFEYE INJECTOR
Received Aug 13, 2024 · Event occurred Jul 12, 2024
Report 0001313525-2024-00144 · MDR key 19974192
Device
Generic name
Folders And Injectors, Intraocular Lens
Manufacturer
Bausch + LombModel number
21987Lot number
2304C3
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, G6, H2, H3, H6, H10. THE DEVICE WAS RECEIVED AND EVALUATED. EVALUATION REVEALED THE PLUNGERS UPPER TIP BROKEN WITH THE PLUNGER ROD ADVANCED UP TO THE CONICAL ZONE AND PROTRUDING FROM THE TIP. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THE REPORTED EVENT. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. CORRECTIVE MEASURES HAVE BEEN IDENTIFIED TO MITIGATE FUTURE SIMILAR OCCURRENCES. BAUSCH & LOMB WILL CONTINUE TO MONITOR SIMILAR EVENTS TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED.
Description of Event or Problem
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. PATIENT RETURNED FOUR DAYS LATER AND AN IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THIS REPORT REFERENCES INJECTOR 2 OF 2. REFERENCE REPORT NUMBERS 0001313525-2024-00141, 0001313525-2024-00142 AND 0001313525-2024-00143.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED UPON CONCLUSION OF INVESTIGATION.