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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Phone: (b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the injector was rotated during the implantation of the intraocular lens (iol) in the patient's left eye and the lens got stuck.The injector went through it.The injector was pushed, however, the lens remained stuck.An incision of 2.4mm was made to implant the aspherical lens.As the injector did not work, a spherical lens was implanted by enlarging the incision to 2.75mm.There has been delay in the procedure.No further information is available.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.Product deficiency could not be determined.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system 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.

• Brand Name: TECNIS ITEC 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: 10984552
• Report Number: 2648035-2020-00918
• Device Sequence Number: 14277622
• Product Code: HQL
• UDI-Device Identifier: 05050474558373
• UDI-Public: (01)05050474558373(17)220813
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 08/13/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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
• Patient Age: 69 YR