MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: unknown, information not provided.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that intraocular lens was explanted from patient left eye due to patient unhappy with decreased visual acuity.The lens was discarded.The replacement lens is a dcb00 18.0 serial number is (b)(4).There were no sutures, incision enlargement or vitrectomy performed.Patient was doing fine post-op.Visual acuity pre-op (pre-initial implant): 20/100.Visual acuity post-op (post-initial implant): 20/30.Visual acuity post-op (post-replacement): 20/20.No further information provided.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12194083
• Report Number: 2648035-2021-08168
• Device Sequence Number: 1322970
• Product Code: HQL
• UDI-Device Identifier: 05050474635982
• UDI-Public: (01)05050474635982(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: 11/30/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• 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