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

Model Number	ZA9003
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted, if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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
During a cataract procedure, the capsular bag tore, resulting in a vitrectomy procedure.A za9003 three-piece intraocular lens (iol) was placed after the vitrectomy procedure, however, once inserted, the 3 piece iol would not sit correctly.An incision enlargement was required to remove the suspected iol and replace with another iol.It was reported the patient outcome is well.
Additional Manufacturer Narrative
Describe event or problem: needs additional information as follows: during a cataract procedure, the original lens a non-johnson and johnson intraocular lens (iol), ended up tearing the capsule while using the phaco machine.Hence, the doctor switched to the suspect iol za9003.As the za9003 iol was inserted, the doctor had difficulty positioning the iol.The suspect za9003 was then removed and replaced with another non-johnson and johnson iol.Device available for evaluation; returned to manufacturer on: 7/19/2019.Device evaluated by manufacturer.Device evaluation: sample was received and the lens was observed under microscope (10x) and no defects were observed.The haptics were observed positioned and without damages.The complaint is related to the lens that after insertion not sit correctly (surgical situation).Complaint could not be verified.A product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-(b)(4) and capa-010215.

• Brand Name: TECNIS
• 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: 8833835
• Report Number: 2648035-2019-00781
• Device Sequence Number: 19467101
• Product Code: HQL
• UDI-Device Identifier: 05050474528840
• UDI-Public: (01)05050474528840(17)201120
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

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: 11/20/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 10/25/2020
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/16/2019; 11/12/2020
• 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005