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

Model Number ZCB00

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after insertion of the intraocular lens (iol) into the patient's left eye, the lens rotated and would not stay in place, but floated away.The lens was removed and replaced in the same procedure.An incision enlargement was required.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 7/30/19.Device returned to manufacturer ¿ yes.Device evaluation: a visual inspection of the lens shows traces of ovd on its surface.The lens was cut halfway through the optic¿s center, most probably to aid in removal.The lens was cleaned with purified water and dried with compressed air to ease inspection.Under magnification, scratching could be seen on the optic and haptic surfaces.The condition of the lens is consistent with that of one that has been handled, inserted, and removed.No obvious defects were observed with the haptics.The complaint event could not be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & 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 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: 8840051
• MDR Text Key: 152601439
• Report Number: 3011852734-2019-00156
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)220729
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

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: 07/29/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• 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: 07/01/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 10/25/2020
• Supplement Dates FDA Received: 09/13/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention