- Device
- AcrySof IQ Aspheric IOL with UltraSert
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P930014
- Supplement
- S140
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the microbiological test method for determination of pre-sterilization bioburden, and a change in the organism used to determine the bioburden enumeration correction factor.