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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided.Best estimate is between (b)(6) 2021 and (b)(6) 2021.If explanted; give date: n/a (not applicable).Lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending 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 a patient with a tecnis eyhance intraocular lens (iol), model dib00, implanted in the left eye on (b)(6) 2021 experienced unexpected post-op refraction.A brief description of the event provided that the patient ended up myopic and was not happy with the results.Follow-up with the account revealed that the surgeon implanted a piggy-back johnson and johnson iol model ar40m in a secondary procedure on (b)(6) 2021.There were no injuries reported and the patient is doing well.The patient has not returned for further treatment.No additional information was 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: 12333609
• Report Number: 2648035-2021-08227
• Device Sequence Number: 16845606
• Product Code: HQL
• UDI-Device Identifier: 05050474731868
• UDI-Public: (01)05050474731868(17)240113
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 01/13/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0250
• 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: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• 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: 64 YR