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

Model Number	PCB00
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was inserted and removed in the same surgical procedure.Additional information was received and it was learnt that doctor implanted the lens and then observed a kinked haptic.The lens was removed and replaced requiring an incision enlargement and sutures.The replacement lens used was the same model and diopter.No patient injury reported and the patient was noted to be doing good at discharge.No further information was provided.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 4/16/2018.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Only the lens from the preloaded system was returned.Visual inspection using microscope magnification was performed.The lens was observed cut in half with both lens haptics distorted/bent, confirming the reported issue.The condition observed in the lens and the way in which the cut is formed is consistent with a lens that has been cut due to ¿iol removal or explant¿.The reported issue was verified.However, there is no evidence to suggest that the returned sample was affected by the manufacturing process.No product deficiency was identified.The complaint issue reported as haptic damaged was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search of the complaint database was performed on (b)(6) 2018 revealed no additional investigation request for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was 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.; santa ana CA
• MDR Report Key: 7435279
• Report Number: 2648035-2018-00533
• Device Sequence Number: 13807145
• Product Code: HQL
• UDI-Device Identifier: 05050474558052
• UDI-Public: (01)05050474558052(17)191211
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: Physician
• Device Expiration Date: 12/11/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 59 YR