MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_MONOFOCAL IOL

Model Number UNK-MONOFOCAL IOL

Device Problem Difficult to Insert (1316)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Event Description

It was reported that an intraocular (lens) was delivered normally into the eye.But the customer noticed at that point that the iol was tilting and then realized the bag was compromised.The customer was not sure if it was due to iol or before iol was used.Vitrectomy was required.The product has been discarded.No other information was provided.

Manufacturer Narrative

Age, weight, and ethnicity: unknown/ not provided.Date of event: unknown, not provided.Best estimated date was several wees ago from when event reported on (b)(6) 2022.Brand name: unknown, as the serial number was not provided.Model number: unknown, as the serial number was not provided.Catalog number: unknown, as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Serial number: unknown, information not provided.Udi number: unknown, as the serial number was not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device 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.Device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_MONOFOCAL IOL
• Type of Device: MONOFOCAL IOL
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14583309
• MDR Text Key: 293272954
• Report Number: 3012236936-2022-01437
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-MONOFOCAL IOL
• Device Catalogue Number: UNK-MONOFOCAL IOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention