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

Catalog Number UNK-MONOFOCAL IOL

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) had sticking haptics.Customer had prepared the shooter as always; however, the haptics were so sticky that they were stuck on the optic of the iol.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: unknown/ not provided.Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3: date of event: unknown/not provided.Section d4: model number, catalog number, serial number, expiration date and udi number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: unknown/not provided.Section d6b: if explanted, give date: unknown/not provided.Section e1: first name, last name, email address: unknown/not provided.Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.As the serial number is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain the missing information.However, to date, it has not 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: 18422020
• MDR Text Key: 331716008
• Report Number: 3012236936-2023-03325
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-MONOFOCAL IOL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• 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