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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens remains implanted.Device evaluation: the product was not returned as the lens remains implanted.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.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.
Event or Problem Description
The customer implanted a tecnis 1-piece monofocal intraocular lens (iol) in the patient¿s left (os) eye.At one day post-op, the customer observed a ¿sticky substance¿ adhering to the posterior side of the lens through a slit lamp.The posterior aspect of the lens has what appeared a string-like substance bluish in color, adhered to the middle of the optic.The customer had to work hard at removing it off the lens.The lens remains implanted since the patient's vision has not been impacted.There is no indication that a planned treatment has been scheduled.No further information has been provided.
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 (b)(4) and capa (b)(4).

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10210362
• Report Number: 2648035-2020-00459
• Device Sequence Number: 3233532
• Product Code: HQL
• UDI-Device Identifier: 05050474531666
• UDI-Public: (01)05050474531666(17)231227
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005