MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCB00
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2021.(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 explanted from patient's right eye as the patient was not seeing clearly with the implant.The incision was reopened and suture was used after the replacement lens was placed into the operative eye.There was no injury and patient was doing well post operatively.No further information available.
Additional Manufacturer Narrative
Correction and additional information: b5: additional: subsequent follow up information received from the surgery center confirms that the replacement lens used was a dcb00 lens 18.0 sn (b)(6).Upon reviewing the complaint folder, it has been determined that as the originally implanted lens was of 16.0d and the replacement lens used was of 18.0d, there is a significant change in the diopter which indicates a calculation issue during the initial surgery.Based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 2020664-2021-07070.H6: additional: medical device problem code: 1189 - application program problem: dose calculation error.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12235645
• Report Number: 2020664-2021-07070
• Device Sequence Number: 3532173
• Product Code: HQL
• UDI-Device Identifier: 05050474531635
• UDI-Public: (01)05050474531635(17)210914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 09/14/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: Required Intervention
• Patient Age: 67 YR