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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/ not provided.If implanted, give date: unknown if lens remains implanted.If explanted, give date: not applicable, there is no indication the lens has been explanted.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after an intraocular lens (iol) was implanted, the patient's capsular bag tore and the iol went into the vitreous.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Further information was provided and reported the lens was remove and replaced during the same procedure.The lens was discarded.It was reported unplanned sutures and a vitrectomy were required.The patient outcome was reported as doing fine.The lens was replaced with another johnson & johnson lens (za9003 18.0 diopter).No other information was provided.The following section has been updated accordingly: section b2: outcomes attributed to adverse event: required intervention.Section b3: date of event: (b)(6) 2020.Section d6: if implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section d7: if explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section h6: patient code 2643- vitrectomy, 3191-unplanned sutures.Device evaluation: the device was not returned at the manufacturing site as it was discarded; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed three other complaints were received under this production order; however, product deficiency were not identified in all three complains.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.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: 10601156
• Report Number: 2648035-2020-00721
• Device Sequence Number: 3620697
• Product Code: HQL
• UDI-Device Identifier: 05050474558236
• UDI-Public: (01)05050474558236(17)230311
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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; Required Intervention
• Patient Age: 83 YR