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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.The search on complaints revealed no additional complaints for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.The lens remains implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002 19.0 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2017.Since then, she has been experiencing double vision which is impacting her life tremendously.The double vision started the day of the surgery, but only to the bottom part of the lens.There are no issues with the top part.Furthermore, starting about one month post-operatively, when the patient goes from a bright room to a dimmer room, her vision becomes totally dark and adjusts gradually after a few minutes as if wearing transition lenses.The patient has reportedly informed her eye care professional regarding this matter, only to have been told that there was nothing they could do about it.The patient has also seen some specialists and was told that her problems may stem from the anesthesia used during her surgery.It was recommended that the patient have surgery in her right eye to shorten the muscle in that eye because they can't repair the damage done the to left eye.The patient''s current vision is 20/20.No additional information was provided.
Additional Manufacturer Narrative
Per external communication provided by the patient; the patient's original inquiry was in regard to a intraocular lens (iol) replacement on left eye (os) in (b)(6) 2017.Immediately upon the removal of patient's eye safety cover that day, the patient noticed that it had significant double vision in both eyes (ou).The physician assured her that this would resolve itself ("in most cases") with a little time.It has not done so.Her right eye (od) surgery was done in (b)(6) 2017 with no issues.The patient's health has been excellent both before and after.In november, the patient fell at night and broke her knee since she was unable to see clearly when looking down.The patient can no longer drive her suv as she sees double yellow lines now.Two (2) issues have arisen: 1) upon her insistence, she was referred to other ophthalmologist.The physician believed that an anterior muscle was paralyzed during the procedure.They prescribed her several different fresnal prism stickers did nothing to improve her vision due to the large diopter discrepancy and variance during the day.The surgeon subsequently said the only solution was to shorten the same muscle in the other eye to try to equalize them, which is not going to happen since it would not help due to the variance.The double vision improves when outside and varies when under artificial light indoors depending upon the distance of the object, which makes the patient wonder if it is really a muscle issue.Also, all examinations take place in a darkened room looking at a bright light, which is the worst possible condition for the patient.2) the second issue occurred about two (2) months after the first surgery.When the patient first awaken or go from a brightly lit room or a dim room, her os now tightens and darkens significantly for a few minutes, almost to the point of blindness in that eye.Also, when in bright sunlight even with polarized sunglasses, her vision is noticeably darker in os the whole time.It has remained the same.Three (3) ophthalmologists that have examined her are all pediatric specialists and none of them have any idea about iol replacement lenses for cataracts.The patient understands that diplopia is more common in children and cannot believe that she is the only adult in the world experiencing these symptoms and that no one can resolve this without paralyzing her other muscles.And not one of them, including her surgeon, wants to hear about the light darkening issue.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7329358
• Report Number: 2648035-2018-00360
• Device Sequence Number: 159946
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)220204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/04/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR