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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown.Sex/gender: unknown.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).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 when inserting a intraocular lens (iol) into the patient's eye, the capsule was unable to support the lens.The iol was removed during the same procedure, and an incision enlargement was required.There was no patient injury, and no additional intervention required.Another lens (different model) was implanted as a replacement.The patient is doing fine post-operatively.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional info: through follow-up the surgeon's name was provided along with the gender and date of birth of the patient.Therefore, the following fields have been updated accordingly.Age/date of birth: (b)(6) 1975.Sex/gender: female.(b)(6).Device evaluation: the explanted lens was received and observed cut in half, most probably to aid in explant.After cleaning with purified water and drying with compressed air to separate the two stuck halves of the lens, the pieces were observed under magnification.No obvious damage or defect could be seen on the haptics.The reported issue could not be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other 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.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 (b)(4) and capa-010215.

• 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: 8698311
• Report Number: 3011852734-2019-00126
• Device Sequence Number: 2663294
• Product Code: HQL
• UDI-Device Identifier: 05050474531888
• UDI-Public: (01)05050474531888(17)220811
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 10/25/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/24/2019; 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
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005