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

Model Number PCB00

Device Problems Unintended Movement (3026); Separation Problem (4043)

Patient Problems Corneal Edema (1791); No Code Available (3191)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) had haptic missing.Additional information was received stating that when the pcb00 lens was implanted into the eye, they noticed that one haptic may be missing.After three to four weeks, patient came back as the lens was not staying in position properly, the lens was explanted/exchanged.The patient was worried, but surgery was uncomplicated.There was no suture or vitrectomy, however, an incision enlargement was required.Also noted is neuro-128 onguent was prescribed by doctor due to corneal edema persistent one-month post-op.Visual acuity pre-op (pre-initial implant): 20/200.Visual acuity post-op (post-initial implant): 20/200.Visual acuity post-op (post-replacement): 20/70 (one month post first surgery).No further information provided.

Manufacturer Narrative

Additional information: device available for evaluation; returned to manufacturer on 2/10/2020.Device evaluation: the product was received at site inside a bag containing a plastic identified container with the lens inside.The lens was evaluated and the following were the observations: lens cut and haptic detached.The other haptic looks in good conditions.The complaint issue was verified, however due the condition of the returned (handled) a product deficiency and malfunction could not be determine.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed no additional investigation requests received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9522337
• MDR Text Key: 176750127
• Report Number: 2648035-2019-01382
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558397
• UDI-Public: (01)05050474558397(17)211108
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/29/2020; 10/25/2020
• Supplement Dates FDA Received: 02/24/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention