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

Model Number	PCB00
Medical Device Problem Codes	Premature Activation (1484); Unintended Movement (3026)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable, lens remains implanted.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 records review: the manufacturing records and related documents for the production order of the device were reviewed and no deviations or discrepancies were found during the mrr (manufacturing record review).The units were manufactured and released according to specifications.A search in complaint system revealed that one additional complaint was received from this production order number which the complaint meets the criteria for no further investigation.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
It was reported that the cataract surgery on the left eye of the patient went fine.The bag was intact.When the lens was pushed out, it snapped and quickly pushed from one line to the next, ejecting the lens and pushing the lens into anterior vitreous.It was indicated that the lens was centered and repositioned in the eye.The lens remains implanted.There is no pain, but the doctor anticipates dizzy vision and is expecting to perform a vitrectomy and an explant.The patient was seen on (b)(6) 2020 and the doctor''s observation and diagnosis is that iol is tilted, appears still centered.The next plan is follow up in two (2) weeks.There is capsule tear noted.However, right now there is no need for medical or surgical intervention such as vitrectomy but the patient still needs it in the future.The patient outcome right now is to wait until one (1) month after surgery.No further information was provided.

• 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: 10738291
• Report Number: 2648035-2020-00778
• Device Sequence Number: 3196250
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)230618
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 06/18/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/26/2020
• 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: Other
• Patient Age: 57 YR