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HEALON5 PRO
JOHNSON & JOHNSON SURGICAL VISION, INC. · Model 10340015 · UDI-DI 05050474807464
LZP
Prescription
0
510(k) clearances
2,822
Adverse events (1 deaths)
25
Recalls
24
Facilities
Description
HEALON5 PRO 0,6 ML US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | Johnson & Johnson Surgical Vision, Inc. | Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, with |
| 2019-12-03 | Johnson & Johnson Surgical Vision Inc | Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2017-04-01 | Abbott Medical Optics Inc. (AMO) | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. |
| 2014-11-06 | Abbott Medical Optics Inc (AMO) | AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally m |
| 2013-11-25 | C.L.R. Medicals International, Inc. | CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the Quality System Regulatio |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.