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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: information unknown/not provided.Device evaluation: the device was received at the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was returned cut in half (but not separated), which is consistent with a lens that was handled during explant.The lens was evaluated by an optical sme (subject matter expert) to determine if the lens can be optically inspected.Per manufacturing sme, ¿the lens was measured on 02/01/2021 resulting in an acceptable power reading of 18.85d¿.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated, and no nonconformity report was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a male patient was implanted with a symfony lens in the right eye (od) on (b)(6) 2020 with 20/25 distance and j2 at near but the patient was not happy with his reading vision.Thus, the doctor decided to use a zmb00 model for fellow (left) eye (os).The patient underwent an uncomplicated flacs, phaco, and intraocular lens (iol), model zmb00 was implanted in left eye (os) on (b)(6) 2020.Reportedly the patient became hyperopic +1.50 d, with 20/60 distance and j2 at near with glare and blurry vision.Blurry vision at distance and near post-op hyperopic surprise was reported.The patient was refracted on (b)(6) 2021 with the following results: od: +0.50 sphere od - 20/25.Os: +1.50-0.25 x 015 - 20/15 with much subjective improvement and loss of the halos.Visual acuity pre-operative: 20/40.Visual acuity post-operative: 20.(b)(6) 2021 - sans correction (sc) 20/60 sc j2.Refraction os: +150 - 0.25 x015 - 20/15.The doctor stated that he did not understand the hyperopic surprise in the left eye (os) as he did the correct measurements; and the 19.0 diopter was supposed to be correct for the patient, however he decided to explant the lens and put in a 21.5 diopter lens of the same model in order for the patient to have a favorable visual outcome.On (b)(6) 2021, the intraocular lens was explanted from the patient¿s left eye.It was confirmed that there is no complaint on the right eye and that the patient just asked for better near.The patient is doing well and no complaints on the replacement lens was reported.No further information provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11320194
• Report Number: 2648035-2021-07247
• Device Sequence Number: 4140071
• Product Code: MFK
• UDI-Device Identifier: 05050474535602
• UDI-Public: (01)05050474535602(17)220918
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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: 09/18/2022
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/12/2021
• 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: 66 YR