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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problems Corneal Edema (1791); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: exact date unknown; within 3 weeks of the implantation date on (b)(6) 2020.Serial#: unknown/not provided.Catalogue#: a complete catalogue # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: unknown as product serial number was not provided.If explanted; give date: lens remains implanted.Phone: (b)(6).Device manufacture date: unknown, as product serial number was not provided.(b)(4).The intraocular lens (iol) is not returning for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the visual acuity deteriorated following yag (yttrium aluminum garnet) treatment.On (b)(6) 2020, the surgeon implanted a tecnics toric with 1.5 cyl in the patient.For the first three weeks visual acuity was good, and then deteriorated.As the patient was assigned to a different eye doctor, the surgeon only saw the patient again on (b)(6) 2020.A capsular contracture developed relatively quickly with a visual acuity of 0.4.On (b)(6) 2020, a yag was performed without any problems, but the revision on the (b)(6) 2020, is now plus 0.5, asti minus 1.0 at 63 degrees.Visus (vision) 1.0.No additional information was provided.

Manufacturer Narrative

Section b5 - describe event or problem: through follow-up we learned that the visus is now with plus 0,5 with cylinder minus 1,0 at 65 degrees.The patient and customer are happy with the result.No additional information was provided.Section d4 - serial#: (b)(6) section d4 - catalogue#: zct1500205 section d4 - expiration date: 2/11/2024 section d4 - udi #: (b)(4).Section h4 - device manufacture date: 2/11/2020 device evaluation: the intraocular lens (iol) was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device could not be completed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have been received.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.

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-010215.

• 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: 10480687
• MDR Text Key: 214138763
• Report Number: 9614546-2020-00357
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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,Followup
• Report Date: 01/01/2005,10/29/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT1500205
• 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: 08/10/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 10/25/2020
• Supplement Dates FDA Received: 09/24/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention