MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number ZCT375

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Explant date: if explanted, give date: not applicable, remains implanted in the eye.(b)(6).(b)(4).Device evaluation: product evaluation cannot be performed as per the initial report, the lens remains implanted.There are multiple factors that could contribute to the reported lens calculation issue, including but not limited too, user error.Without further information provided the complaint issue reported could not be verified 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.A search revealed that no other complaints have been received for this production order.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.

Event Description

It was reported that the (b)(6) jnj calculation service mistakenly swapped the axes when calculating the toric iol.Additional information was provided stating the physician will rotate the lens.Further information provided confirmed the lens was rotated.Pre-op the patient was -14,5 +5,75 cylinder 120, post rotation the patient¿s vision in right eye is at 0,6.Remaining astigmatism +1,0/70 degrees.Explant is not necessary.No further information 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 (b)(4) and capa(b)(4).

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9827965
• MDR Text Key: 183377471
• Report Number: 2648035-2020-00254
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474588110
• UDI-Public: (01)05050474588110(17)240716
• 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
• Report Date: 01/01/2005,11/02/2020

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 Model Number: ZCT375
• Device Catalogue Number: ZCT3750110
• 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: 02/13/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR