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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Vitrectomy (2643); No Code Available (3191)
Date of Event	12/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided, however it was reported that symptoms became bothersome two months post-implant, therefore (b)(6) 2016 is entered.If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other 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.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted in the patient's left eye and the patient was not happy as patient could not focus correctly especially when driving.The patient also complained vision was blurry, hazy, and colors were not rigid.At this time, the lens remains implanted.No other information was provided.
Additional Manufacturer Narrative
Additional info: further information was provided and reported patient''s vision became bothersome a couple of months after the surgery in the left eye.Multifocal intolerance was exacerbated by the patient''s astigmatism caused by the flattening from the femtosecond laser arc at 5pm.No other information provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: further information was provided, and the lens was explanted.A pars plana vitrectomy and a limbal relaxation incision (new incision was made) were required.A non-johnson & johnson replacement lens was implanted.Patient''s vision has improved; the colors are brighter, and the blurriness, glare, and halos have improved.No additional information was provided.The following sections have been updated accordingly: section d7: if explanted, give date: (b)(6) 2020.Section h6: patient codes: 2643, 3191 ¿ explant of lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 8/10/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and the lens was received cut in half; which is consistent with a lens being handled during explant.Based on the returned condition of the lens, no further product evaluation can be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: during the manufacturing records review the documentation shows that the production order was manufactured and released according to specification.A search of complaints was performed on august 11, 2020.The 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 & johnson surgical vision, inc.Has been submitted.
Additional 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 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10037097
• Report Number: 9614546-2020-00197
• Device Sequence Number: 2502427
• Product Code: MFK
• UDI-Device Identifier: 05050474560734
• UDI-Public: (01)05050474560734(17)200320
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/16/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 08/11/2020; 10/25/2020; 10/19/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/24/2020; 09/03/2020; 10/30/2020; 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: Other
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005