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

Model Number	ZCT150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.  (b)(4).Device evaluation: product testing could not be performed since the lens is still implanted in the patient's eye.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.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 additional complaint was received from 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zct150 intraocular lens (iol) was repositioned due to pseudophakodonesis.Medical/surgical interventions that were performed are iol repositioning, pars plana vitrectomy (ppv), use of capsular retractors, capsular tension set ring, and placement of 2 capsule tension segments sutured in place.Patient is happy with the vision and iol is in good position.Additional details received states that there is no "degree" of rotation of the iol and the reason for the repositioning was pseudophakodonesis - which is movement/jiggling of the iol.Patient's first complaint of blurry vison in the right eye (od) was on (b)(6) 2019.Vision was 20/25+2 with correction.Doctor documented pseudophakodonesis then advised to observe.Patient returned on (b)(6) 2020 with the same complaint of blurry vision - 20/25 with correction in the right eye and advised to observe.Patient returned again on (b)(6) 2020 with complaint of blurry vision - 20/30 with correction then doctor advised surgery to lasso the iol.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10849062
• Report Number: 9614546-2020-00482
• Device Sequence Number: 16946487
• Product Code: HQL
• UDI-Device Identifier: 05050474551947
• UDI-Public: (01)05050474551947(17)180224
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2018
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR