MAUDE Adverse Event Report: JOHNSON & 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 Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

If implanted: if explanted: not applicable, as the intraocular lens was inserted and removed in the initial surgery.Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was implanted and explanted.Through follow-up, additional information was received stating iol was explanted (removed) after a rupture of the posterior capsular bag was noted during the removal of viscoelastic.Lens was explanted (removed) without difficulty and was not related to a product quality issue.A sulcus iol was implanted during the same procedure after anterior vitrectomy was performed.The patient is doing well.No further information is available.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10730982
• MDR Text Key: 214801471
• Report Number: 2648035-2020-00772
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558366
• UDI-Public: (01)05050474558366(17)230728
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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
• Patient Age: 71 YR