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

Model Number	DIU150
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: is unknown/no information.Best estimate is during (b)(6) 2021.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that a post-lasik patient ended up off target and an explant/exchange of the intraocular lens (iol) for a better power iol is planned.Through follow-up explant of the iol was confirmed.Reportedly, the patient is doing well.No further information is available.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.
Additional Manufacturer Narrative
Corrected data: the implant and explant dates were left blank in the initial mdr.The correct information is as follows: d6a.If implanted, give date (b)(6) 2021 d6b.If explanted, give date (b)(6) 2021 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS EYEHANCE
• 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: 11891984
• Report Number: 2648035-2021-07750
• Device Sequence Number: 1390026
• Product Code: HQL
• UDI-Device Identifier: 05050474746572
• UDI-Public: (01)05050474746572(17)240118
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 07/04/2021

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: 01/18/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U215
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/29/2021; 07/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/24/2021; 07/04/2021
• 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