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

Model Number DCB00V

Device Problem Break (1069)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.Phone number: unknown, information not provided.This report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the unites states under pma p980040.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was found to be scratched and cracked after the lens was implanted in a patient's eye.It was indicated posterior capsule damage occurred when irrigation/aspiration (ia) was used after implant.Therefore, a vitrectomy was required, and an incision enlargement to remove the iol.The iol was replaced with a non-johnson & johnson lens.In the postoperative examination, the visual acuity of the naked eye was 1.0 and stable.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes; returned to manufacturer on: february 20, 2021 device evaluated by manufacturer? yes device evaluation: the complaint sample was received in its original packaging.Upon evaluation of the device, the screw plunger was in a fully advanced position, the pushrod looks centered.All the components were correctly engaged.There was no assembly error and/or defect that could be related to manufacturing process was identified.Traces of lubricant material residue was observed in the device.The lens was received outside the device and no damaged was identified on it.The device was disassembled to verify the components conditions, and all were observed in good conditions.Based in the analysis of the sample returned product the reported issue was not verified, and quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated, and no discrepancies and/or deviation were found during the mrr (manufacturing record review) related to this complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no additional complaint was received for this production order number.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.

• Brand Name: TECNIS OPTIBLUE 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
• MDR Report Key: 11092570
• MDR Text Key: 258636228
• Report Number: 2648035-2020-00972
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636712
• UDI-Public: (01)05050474636712(17)230928
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: DCB00V
• Device Catalogue Number: DCB00V0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention