TECNIS Multi-focal 3-pc, Model ZMA00
Johnson & Johnson Surgical Vision, Inc. · Lens, multifocal intraocular · Ophthalmic
Open FDA's page for this record- PMA number
- P080010
- Supplement number
- S032
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Street 1
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- Zip
- 92618
- Generic name
- Lens, multifocal intraocular
- Trade name
- TECNIS Multi-focal 3-pc, Model ZMA00
- Product code
- MFK
- 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
- Lens, Multifocal Intraocular
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.3600
- Device class
- 3
- Registration number
- 9613160, 1038833, 3015456951, 3010155661, 9681121, 1119421, 2648035, 9612169, 3012304651, 3003304724, 1610287, 1119279, 9614546, 3017636737, 1313525, 1063199, 3012236936, 3007530141, 3002807314
- FEI number
- 1038833, 3001659659, 3015456951, 3001284430, 3010155661, 1119421, 2648035, 3012304651, 3004651700, 3003304724, 1610287, 1119279, 3017636737, 1317628, 3002808262, 3012236936, 3007530141, 3002807944, 3002807314