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

Model Number	ZCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had a broken sac (capsular bag) with an intraocular lens (iol) as it was partially inserted.Another johnson & johnson lens (different model, za9003 and lower diopter 24.0) was implanted as a replacement.The outcome does not significantly interfere with daily activities.The patient has recovered.No further information was available.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 12/10/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was not received in its original lens case.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half (not separated), which is consistent with a lens that was handled.Furthermore, both haptics were observed to be bent, however the lens was returned crushed and not centralized in the lens insert, and therefore, this cannot be confirmed to be related to manufacturing.The complaint issue could not be confirmed, because the lens was returned outside/without a cartridge tip, and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.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 1-PIECE
• 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: 10873196
• Report Number: 2648035-2020-00879
• Device Sequence Number: 14168893
• Product Code: HQL
• UDI-Device Identifier: 05050474531802
• UDI-Public: (01)05050474531802(17)240713
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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: Other
• Patient Age: 80 YR