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

Model Number	DCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.If explanted: not applicable as the iol remains implanted.Device evaluation: as the device remains implanted no returned product evaluation can be conducted.According to initial report: the particle was evacuated right away.Since product and foreign matter are not available, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing record evaluation: the manufacturing process records were reviewed.There are no discrepancies found during the mrr (manufacturing record review) related to this complaint.The units were released according specification in compliance with the product intended use as required.A search was conducted and revealed no additional complaint folders for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality 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
After intraocular lens (iol) was implanted in the patient¿s operative eye it was reported the doctor noticed a small gray particle or material in the eye.The particle was evacuated right away.Through follow-up, additional information was received confirming no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), no unplanned vitrectomy, the reported grey particle, or material is not available for testing.Patient outcome was reported as excellent.No further information was provided.

• Brand Name: TECNIS SIMPLICITY PRELOADED 1-PIECE IOL
• 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: 10988962
• Report Number: 2648035-2020-00923
• Device Sequence Number: 792027
• Product Code: HQL
• UDI-Device Identifier: 05050474636200
• UDI-Public: (01)05050474636200(17)230227
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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
• Report Date (Section B): 12/10/2020

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: 02/27/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1