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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight/ethnicity: information unknown/not provided.Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2020 and (b)(6) 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's operative eye due to the patient has keratoconus.Visual acuity pre-op: 20/400 20/70 +2 uncorrected - pinhole.Visual acuity post-op: 20/200 20/40 +2 uncorrected - pinhole.There was no vitrectomy, incision enlargement, or sutures required.Another johnson & johnson lens (different model and diopter) was implanted as a replacement.The patient is very happy with the outcome.No further information is available.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that in the initial mdr the patient had keratoconus in section b5, which is a pre-existing condition, that can cause diminished visual acuity.The keratoconus refractive effect can be corrected with toric/astigmatic refraction in some cases.In this case, it appears the patient was initially implanted with a monofocal intraocular lens implant, which would not address the astigmatic refractive status due to the keratoconus.Thus subsequently, the lens initially implanted was explanted approximately 3 months later after the primary procedure, and was replaced with a toric lens implant, with the patient reportedly very happy with the results thereafter.Therefore, event is no longer considered a reportable serious injury and no further information will be provided under manufacturer report number 2648035-2021-07747.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): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11803471
• Report Number: 2648035-2021-07747
• Device Sequence Number: 3634842
• Product Code: HQL
• UDI-Device Identifier: 05050474531482
• UDI-Public: (01)05050474531482(17)220829
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/17/2021

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: 08/29/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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