MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER HANDPIECE; LENS, GUIDE, INTRAOCULAR

Model Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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.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.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular ( iol) lens was inserted but was removed and replaced by the surgeon using micro instrument during the same procedure, as the inserter damaged the lens.The incision was enlarged, no sutures required, a delay of 5 minutes was reported.The customer have no further information to report.
Additional Manufacturer Narrative
Correction: upon further review, it was determined that the suspect product is the injector, model and lot number are unknown and not the aab00 iol.Therefore, this supplemental filing is to correct section d brand name, common device name, product code, model number, catalog number, lot number, and udi.Section d1: brand name: unknown, as the lot number was not provided.Section d4: model number: unknown, as information was not provided.Section d4: catalog number: unknown, as information was not provided.Section d4: lot number: unknown, information not provided.Section d4: expiration date: unknown as product lot number was not provided.Section d4: udi number: unknown, as the lot number was not provided.Section d6a: if implanted; give date: n/a (not applicable).The unfolder is not an implantable device.Section d6b: if explanted; give date: n/a (not applicable).The unfolder is not an implantable device.Section d10: concomitant product: aab00 iol sn (b)(6).Section h3-other (81): the device was not returned for evaluation and the lot number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the lot number was not provided.Attempts have been made to obtain missing information.However, the account did not have the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER HANDPIECE
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 17186881
• Report Number: 3012236936-2023-01431
• Device Sequence Number: 15086652
• Product Code: KYB
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown