MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

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

Patient Problems Dry Eye(s) (1814); Nausea (1970); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

The intraocular lens remains implanted.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a female patient had a monofocal intraocular lens (model pcb00 +24.5 diopter) implanted in the left eye (os) on (b)(6) 2017 and an intraocular lens (model pcb00 +24.0 diopter) implanted in the right eye (od) on (b)(6) 2017.Reportedly, the patient wanted to get distance vision in both eyes but got near vision on the left eye and distance vision in the right eye.The surgeon suggested to performed a yag (yttrium aluminium garnet) procedure to remove clouding on capsule that developed since surgery.The patient asked for a second opinion and the second doctor stated that a yag was not required.There are currently no plans to perform a yag or any other surgical procedures.There have been no injuries.The patient was suggested to wear dark glasses and have a second set of reading glasses.The patient was also seen by a third doctor who prescribed steroid drops.The patient is experiencing dry eye, possibly due to brain adjustment post-surgery.The patient feels nauseous / light headed ¿ sometimes headache is present.The patient states there is not migraine.The specialist at thomas eye had patient purchase: ocusoft eye lid scrub.Symptoms are reported to be unbearable.The patient cannot read or see distance.The eyes are red & bloodshot.The patient needs to wear dark sunglasses constantly.No additional information was provided to johnson and johnson surgical vision, inc.This report is to record the lens implanted in the right eye.A separate report will be filed for the lens implanted in the left eye.

Manufacturer Narrative

Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date 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 intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7410154
• MDR Text Key: 104799625
• Report Number: 2648035-2018-00488
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)200126
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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
• Device Operator: Physician
• Device Expiration Date: 01/26/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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): Required Intervention