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

Model Number DCB00

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

Patient Problems Deposits (1809); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Weight and ethnicity: unknown/no information.Date of event: the exact date is unknown, the best estimate is after (b)(6) 2021 as that is the date the iol was implanted.If explanted, give date: not applicable as the lens remains implanted.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.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

A patient who is also a doctor, reported that he was in a car accident.He had a corneal transplant back in (b)(6).However, johnson & johnson surgical vision (jjsv) records, patient implant card indicate the jjsv intraocular lens (iol) was implanted in (b)(6) 2021.The patient reported that he had a corneal transplant, stitches were installed, the lens was put in at the same time and the traumatic cataract was removed.The patient was informed that his healing is going very well.That because he leads a very healthy lifestyle, his healing would be faster than the average person and it would be maybe 3-6 months before the stitches would be removed.When the stitches were removed, the doctor told the patient that his eye looked like it had been healing for a year.Two months later they had 2/3 of the stitches removed and his doctor said there were 3 left that would dissolve in about in a month.That would have been in (b)(6).The doctor said his vision would be blurry.In (b)(6), the patient's vision was not getting any better, so he got a second opinion.The doctor told him he had 6 stitches and underneath the lens he had scar tissue that the doctor would need to laser off.The patient confirmed that the iol was implanted at the same time he had the corneal transplant.He reiterated that because he was in a car accident it was a traumatic cataract and not degenerative.The patient said that he was almost seeing perfectly clear.However, the doctor told him that the stitches were pulling the lens.The patient thought the stitches might be the cause, so he asked for the stitches to be removed.He reasoned he can work his way to clear vision and would have been fine.But then he was informed he has scar tissue underneath the lens.The patient asked his doctor to remove the iol and replace it.However, his doctor said he cannot do that.Instead, his doctor recommended laser surgery and explained to the patient that he will probably need to get a contact lens.No further information was provided.

Manufacturer Narrative

Corrected data: this is to correct the initial mdr which stated this event is reportable.Upon further review of this event by the jnj medical staff it was determined that it is not reportable.The sutures (stitches) in this case are standard practice because the patient had been in a car accident and consequently required a corneal transplant.In such cases sutures are standard practice therefore, this event is no longer reportable.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12593452
• MDR Text Key: 275466531
• Report Number: 2020664-2021-07576
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636002
• UDI-Public: (01)05050474636002(17)240210
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention