MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN; MONOFOCAL IOLS

Model Number UNKNOWN

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

Patient Problems Intraocular Infection (1933); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2018.If explanted; give date: not applicable; there is not indication lens has been explanted.Brand name: unknown/not provided.Serial#: unknown/not provided.Catalog/ model#: catalog and model # unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: udi # is unknown as product serial number was not provided.Device manufacture date: unknown, as the serial number of the device was not provided.The device was not returned for analysis (the lens remains implanted).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

A female patient reported that she had cataract surgery performed on both eyes (ou) on (b)(6) 2018.Reportedly, days later, the patient complained to a group of friends that she had infections in both eyes because of the surgery.The patient reported that she had an epi-retinal flap in both eyes, and that the retina doctor told her that some people with that experience swelling around the flaps after eye surgery.The patient also confirmed that her intraocular lenses (iols) were from johnson and johnson surgical vision.No additional information was provided.This report pertains to the patient'' left eye (os).A separate mdr report will be submitted for the patient's right eye (od).

Manufacturer Narrative

This supplemental report pertains to left eye (os); per follow-up, the patient's infection has nothing to do with her lenses.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNKNOWN
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7528296
• MDR Text Key: 108722449
• Report Number: 2648035-2018-00736
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• 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