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

Model Number ZCB00

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

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

If implanted, if explanted give date: not applicable, as the intraocular lens was inserted and removed in the initial surgery.(b)(4).Device evaluation: no lens was received with the returned product for this investigation request (ir).The lens case, folding carton, patient stickers, patient id card, and implant notification card were received.No complaint lens was received; therefore, no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.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 other 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 fully implanted in the patient¿s ocular dexter (right eye) when the capsular bag broke.The lens removed and replaced with an anterior chamber lens, model ar40e, 6.0 diopter.The incision was enlarged, and vitrectomy was performed.Patient outcome was reported as fine, but patient was unhappy that the capsular bag was torn.Further information stated that the patient had been poked in the eye which caused a traumatic injury prior to the procedure/implant.In evaluation of this, it was noted cataracts forming.The eye was weakened by this injury, and when implanting the new lens, the bag broke.No further information is available.

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 (b)(4) and capa:(b)(4).

• Brand Name: TECNIS 1-PIECE
• 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: 10434635
• MDR Text Key: 205280836
• Report Number: 2648035-2020-00630
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474534629
• UDI-Public: (01)05050474534629(17)230711
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR