SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS OptiBlue 1-P
Johnson & Johnson Surgical Vision, Inc. · intraocular lens · Ophthalmic
Open FDA's page for this record- PMA number
- P980040
- Supplement number
- S186
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Street 1
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- Zip
- 92618
- Generic name
- intraocular lens
- Trade name
- SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS OptiBlue 1-P
- Product code
- HQL
- Advisory committee
- OP
- Advisory committee description
- Ophthalmic
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-21
- Decision date
- 2026-10-19
- Decision code
- OK30
- Ao statement
the transfer of microbiology testing from an external contractor to an in-house laboratory to support product manufacturing at the AMO Puerto Rico manufacturing site
- Harmonized identifiers (openFDA)
- Device name
- Intraocular Lens
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.3600
- Device class
- 3
- Registration number
- 9613160, 1038833, 3013202565, 3015456951, 3010155661, 2030624, 1048735, 3017435679, 3014002883, 9681121, 1119421, 9612169, 2648035, 3010413216, 1054811, 3014173684, 3008344633, 3006723646, 3012304651, 2438659, 2023826, 3010126268, 3007207818, 3006946276, 1281950, 9710098, 3003304724, 3024715547, 2032098, 1610287, 2031928, 2031959, 1119279, 2011171, 9614546, 3017636737, 1037089, 9614429, 9681630, 3008449456 +17 more
- FEI number
- 1038833, 3013202565, 3001659659, 3015456951, 3001284430, 3010155661, 1048735, 3017435679, 1000121259, 3014002883, 1119421, 2648035, 3010413216, 3014173684, 3008344633, 3002936283, 3002777043, 3006723646, 3012304651, 3004651700, 2023826, 3010126268, 3007207818, 3006946276, 1281950, 3003088462, 3003304724, 3002023310, 3024715547, 1000306431, 3002807944, 1610287, 1119279, 2011171, 3017636737, 1037089, 3003058448, 1317628, 3002808262, 3002808259 +17 more