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

Model Number DCB00

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problems Vitrectomy (2643); Zonular Dehiscence (2698)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Serial number: unknown/not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi number: a complete udi # is unknown as product serial number was not provided.If explanted; give date: not applicable, lens remains implanted.(b)(6).Device manufacture date: unknown, as the serial number was not provided.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: manufacturing record review cannot be performed since the serial number is unknown.A search of complaints related to serial number cannot be performed since the serial number is unknown.No sample was returned, and the serial number is unknown an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the haptics adhered to each other when the intraocular lens (iol) was implanted.When the lens was moved to unstuck the haptics, the loss of the zinn's band was noticed and they had to perform a vitrectomy.No further information was provided.

• Brand Name: TECNIS SIMPLICITY PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11099400
• MDR Text Key: 228896920
• Report Number: 2648035-2020-00979
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• Reporter Country Code: JP
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention