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

Model Number	ZKB00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is between (b)(6) 2015 and (b)(6) 2020.(b)(4).All pertinent information available to (b)(6) surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis multifocal intraocular lens (iol) was explanted from the patient's right eye due to mechanical complication.Additional surgical intervention was not required.Reportedly, there was no patient injury.No further information was provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: (b)(6) 2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was received in a specimen cup.Visual inspection under magnification revealed what appeared to be dried blood and viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.Furthermore, a bent haptic was observed, which can be attributed to the dried viscoelastic sticking the lens to the specimen cup, which may have then bent upon unsticking from the cup.The lens was cleaned and the bent haptic was no longer observed, however haptic damage was observed.Dimensional inspection was performed, and all measurements were within specifications.The complaint issue could not be confirmed, 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.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.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: 10475424
• Report Number: 9614546-2020-00352
• Device Sequence Number: 2949458
• Product Code: MFK
• UDI-Device Identifier: 05050474560017
• UDI-Public: (01)05050474560017(17)181029
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2018
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 10/25/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/25/2020; 10/29/2020
• 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
• Date Report Sent to FDA: 01/01/2005