MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PHACOFLEX II; MONOFOCAL IOLS

Model Number SI40NB

Device Problem Unintended Movement (3026)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Vitrectomy (2643)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

If explanted; give date: not applicable as the iol remains implanted in the patient's ocular dexter (right eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s eye therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Secondary surgical intervention - lens repositioned.Device evaluation: product testing could not be performed because the product was not returned as the lens remains implanted in the patient's ocular dexter (right eye).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 investigation request (ir) associated to the manufacturing date and/or production order number has been received (based on the provided serial number).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 a model si40nb 17.0 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 1998.The lens was within the capsular bag bobbing around in the anterior vitreous cavity just behind the iris.The lens was sunken by about 3mm inferiorly and was repositioned on (b)(6) 2019 with scleral fixation and a pars plana vitrectomy as the patient presented with 20/150 uncorrected vision, and complained of blurry vision.Patient was limited in her daily functions due to decreased vision.Uncorrected vision on (b)(6) 2019 was 20/80-2.The remains implanted in the patient¿s eye.No additional information was provided.

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-(b)(4) and capa-010215.

• Brand Name: PHACOFLEX II
• 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: 9374119
• MDR Text Key: 169209080
• Report Number: 2648035-2019-01248
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474523258
• UDI-Public: (01)05050474523258(17)220205
• Combination Product (y/n): Y
• PMA/PMN Number: P880081
• 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: 01/01/2005,11/05/2020

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: 10/31/2002
• Device Model Number: SI40NB
• Device Catalogue Number: SI40NB0170
• 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
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR