| | Class 2 Device Recall TECNIS Eyhance IOL |  |
| Date Initiated by Firm | July 06, 2023 |
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| Date Posted | August 03, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2289-2023 |
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| Recall Event ID |
92666 |
| PMA Number | P980040S117 |
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| Product Classification |
intraocular lens - Product Code HQL
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| Product | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only |
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| Code Information |
UDI-DI: N/A/ Serial Numbers:
8046642236,
8046652236,
8046662236,
8046672236,
8046682236,
8046692236,
8046702236,
8046712236,
8046722236,
8046732236,
8046742236,
8046752236,
8046762236,
8046772236,
8046782236,
8046792236,
8046802236,
8046812236,
8046822236,
8046832236,
8046842236,
8046852236,
8046862236,
8046872236,
8046882236,
8046892236,
8046902236,
8046912236,
8046922236,
8046932236,
8046942236,
8046952236,
8046962236,
8046972236,
8046982236,
8046992236,
8047002236,
8047012236,
8047022236,
8047032236,
8047042236,
8047052236,
8047062236,
8047072236,
8047082236,
8047102236,
8047112236,
8047122236,
8047132236,
8047142236,
8047152236,
8047162236,
8047172236,
8047182236,
8047192236,
8047202236,
8047212236,
8047222236,
8047232236,
8047242236,
8047252236
|
Recalling Firm/
Manufacturer |
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr Ste 200
Irvine CA 92618-2302
|
Manufacturer Reason
for Recall | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On June 07, 20223, Johnson & Johnson Vison issued an "Urgent: Medical Device Recall" notice to affected consignees. Consignees were asked to take the following actions:
1. Identify if any of your inventory contains TECNIS IOLs from the list on pages 5-6 (see page 4 for label examples).
2. Remove all affected TECNIS IOLs from your inventory. No other TECNIS IOLs are affected by this recall.
3. Complete the attached Customer Reply Form (on page 3). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory.
4. Follow the specific instructions included in the letter "If you have product to be returned" or "If you do not have product to be returned"
5. Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred.
6. If you have product complaints or adverse events to report regarding the use of the affected TECNIS IOLs, please inform Johnson & Johnson Vision. If you do report a complaint, please provide the TECNIS IOL serial number and, if a patient was involved, the date of surgery, a description of the event and patient outcome.
7. In addition, you may report any adverse events experienced or quality issues with the use of the TECNIS IOLs to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch/report.htm. |
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| Quantity in Commerce | 61 units |
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| Distribution | International distribution to the countries of China, India, Korea. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = HQL
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