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

Model Number UNKNOWN

Device Problem Material Opacification (1426)

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

Event Type  malfunction  

Event Description

It was reported that an unknown monofocal intraocular lens (iol) had a product defect.That foreign substance on the optic of this lens could not be removed.It was unknown if there was injury and surgical and medical interventions were required.The lens was removed.No information about replacement iol.No further information is available.

Manufacturer Narrative

Section a2, a4, and a5: unknown/not provided.Section b3 - date of event: unknown/not provided.Section d4 - serial number: unknown/ not provided.Section d4 - catalog number: a complete number is unknown, as product serial number was not provided.Section d4 - expiration date: unknown, as product serial number was not provided.Section d4 - udi number: unknown, as product serial number was not provided.Section d6a - implant date: unknown/ not provided.Section d6b - explant date: unknown/ not provided.Section h3: other 81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has 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.

• Brand Name: UNK_MONOFOCAL 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: 18773081
• MDR Text Key: 336970793
• Report Number: 3012236936-2024-00303
• Device Sequence Number: 1
• Product Code: HQL
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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-MONOFOCAL IOL_UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• 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