MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number DIB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Decompensation (1790); Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: date unknown/ not provided.Serial#: unknown/not provided.Catalog #: a complete catalog # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: unknown as product serial number was not provided.Implant date: unknown, information not provided.If explanted, give date: not applicable as the device remains implanted.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported by the surgeon that a patient who was treated with an eyhance intraocular lens in one eye was seeing a shadow next to the objects in the distance three months after the operation.The patient is also bothered by the fact that compared to the non-operated eye, with which he was seeing well, he could not see as well up close.Through follow up, it was learned that the patient was operated in (b)(6)2022 and had advanced cornea guttata and a normal macula.No further information was provided.

• Brand Name: TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14441804
• MDR Text Key: 294383863
• Report Number: 3012236936-2022-01300
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: UNK-DIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male