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

Model Number UNKNOWN

Device Problem Material Opacification (1426)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4, and a5: unknown; requested but not provided.Section b3: date of event: unknown; requested but not provided.The best estimate date is prior to apr 5, 2024.Section d4: model number: unknown; requested but not provided.Section d4: serial number: unknown; requested but not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: unknown, information was requested but not provided.Section d6b: if explanted, give date: unknown, information was requested but not provided.Section e1: telephone number: (b)(6).Section h3 - other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.A review of the customer provided photos will be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon has noticed a recurring issue with preloaded intraocular lenses (iol), where during implantation, it is noticed that there is a stain on the periphery of the lens.The surgeon thinks the problem is with the simplicity injector.No further information was provided.This report is to capture the recurring issues of stain on the periphery of the lens with unknown event dates.

• Brand Name: UNK_PRELOADED IOL
• Type of Device: INTRAOCULAR LENS
• 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: 19188609
• MDR Text Key: 341789998
• Report Number: 3012236936-2024-01240
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-PRELOADED IOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• 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