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

Model Number GIB00

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) issue of sticking haptics during implantation still persists.Additional maneuvers and an instrument are being used to unlock the haptics.The iols remain implanted.Account indicated that this negatively impacts the surgeon as the sticky haptics have become worse compared with other lenses.No further information was provided.

Manufacturer Narrative

Section e1: telephone number: (b)(6).Section h3: other (81): the intraocular lenses (iol) were not returned for evaluation as they remain implanted.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.Section h4:device manufacture date: unknown, as product serial number was not provided.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 17044290
• MDR Text Key: 317230131
• Report Number: 3012236936-2023-01264
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIB00
• Device Catalogue Number: GIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• 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